17. Before we decide if we should conduct a detailed investigation of a complaint, we look at whether there are signs of service failings or maladministration which the organisation has not put right and whether any injustice identified remains unremedied. Having done so we have found the Trust followed its policies correctly and took learning from the surgery.
Avoidable burns
18. On 13 September 2024, Ms E underwent surgery to remove breast cancer.
19. Ms E says prior to surgery the ‘general risks of the surgery were discussed, but at no point was there any mention of the risk of being burned’. Her medical records contain a handwritten consent form of poor legibility.
20. A diathermy was used for Ms E’s procedure. The diathermy uses heat to cut the patient’s skin and seal the blood supply from any cuts made. When undertaking surgery, surgeons choose two settings; one to cut the patient’s skin and one to seal the blood supply. The settings used during this surgery are expressed in Watts and have been noted as 30/30.
21. The pathology report showed Ms E’s breast tumour was 2 mm from the skin surface.
22. The medical records indicated the surgery was successful with the prognosis noted as excellent. They also note Ms E showed more redness than expected at the sites of the surgical drape and pulse oximeter.
23. The diathermy machine was tested on 17 September 2024 and found to be functioning normally.
24. GMC guidance on consent explains clinicians must discuss common or significant risks of the specific procedure. In breast cancer surgery, the standard risks include bleeding, infection, scarring, and changes to breast shape.
25. There is no single national protocol for the type of breast cancer removal Ms E had. Our adviser told us surgical textbooks outline broad principles, but the exact steps vary depending on tumour location, breast size, and the need to preserve cosmetic appearance. There are many variations of breast operations, and surgeons are expected to change their approach using their professional judgement.
26. Our adviser explains there are no guidelines or standards that make specific diathermy settings mandatory. This is because diathermy settings must be adjusted according to the tissue type, the depth of dissection, and the surgeon’s technique. Surgeons rely on their training and experience to select appropriate power levels. Settings of up to 45/45 Watts are common.
27. Our adviser told us the normal process for diathermy use is for a nurse pass to the diathermy instrument to the surgeon when they need it and retrieve it immediately afterwards. When not in use, the diathermy instrument is usually placed in a protective holster or thick plastic tube.
28. Our adviser made it clear that whilst every step should be taken not to cause inadvertent injury, the primary aim of surgery is to remove all cancerous tissue with an adequate margin of healthy tissue. Preserving the skin is secondary.
29. Our adviser told us accidental injury, including diathermy injury, is recognised in surgical practice but is not a common complication. He explains, in his own experience, he considers complications resulting in diathermy burns are rare.
30. We have not been able to understand what was documented on Ms E’s consent form, and Ms E’s evidence indicates diathermy burns were not discussed. Given the GMC guidance states common or significant risks are discussed we do not find potential diathermy burns would need to be listed on any consent form or in any conversations prior to the surgery as these complications are rare.
31. Our adviser considered the diathermy settings were appropriate for this type of surgery and fall within normal practice. He confirmed it does not indicate excessive power or unsafe technique.
32. Given the proximity of the tumour to the skin, our adviser told us this meant there was very little scope to leave more healthy tissue without the risk of leaving cancerous tissue. Our adviser’s view was that the surgeon took the tumour as close to the skin as safely possible. They concluded nothing in the documentation suggested any deviation from recognised technique.
33. This aligns with the primary aim of surgery being to ensure the complete removal of the cancer, even if this increases the risk of superficial heat damage.
34. Regardless of the clinical explanations, it is clear this has been a distressing time for Ms E. We appreciate undergoing cancer surgery is already an emotionally and physically demanding process and discovering the injuries afterwards has understandably caused her additional worry and upset. It is clear from what Ms E said that these injuries occurring have added to her anxiety. We are sorry for the additional distress this situation has caused.
35. Our adviser told us surgical and dermatological literature recognises that breast skin is generally thinner than skin on the back, limbs, or abdomen. While we cannot determine the exact impact skin sensitivity could have caused, it is reasonable to suggests Ms E’s skin may have been more sensitive than expected. This could have contributed to the degree of redness and reaction seen after surgery, although it cannot be stated with certainty.
36. Taking all the evidence together, diathermy related burns are a recognised, though uncommon side effect of breast cancer surgery particularly when the tumour lies very close to the skin, as in Ms E’s case. The primary aim of surgery is to remove all cancerous tissue with an adequate margin; preserving the skin envelope is secondary. The surgeon’s actions were clinically appropriate and consistent with good surgical practice. We have not found evidence anything went seriously wrong in the way the primary burn was made.
37. The Trust concluded the secondary burn was unintended and was more likely than not because of human error. Our adviser reached the same view.
38. The diathermy tip can become very hot during use. Our adviser concluded it is likely the hot tip briefly touched the skin fold during the operation. Because the area may have been bloody, it may not have been visible at the time. This type of contact burn can occur in close surgical fields and does not indicate negligence; it is best described as inadvertent damage.
39. All parties accept the injury occurred. When we see an incident like this has happened, we look to see that the organisation has taken it seriously and has taken appropriate action to recognise the impact it had on the individual, to take learning, and improve its service.
40. As a result of this incident the Trust confirmed it would ensure all members of the breast team were reminded of the importance extra care is taken when using diathermy equipment, and it would arrange further discussions at a team meeting. The Trust have apologised to Ms E for the burns that occurred.
41. We can see the Trust has taken action in line with our NHS Complaint Standards which say the NHS should see complaints as an opportunity to develop and improve its services and people and GMC guidance which says it should record complaints data and share learning in its own organisation. Whilst we recognise the difficulties that Ms E has experienced, based on the relevant standards, we cannot see any indications the Trust needs to take any further action.
Communications involving duty of candour and complaint investigation
42. Ms E was unhappy with the communications during the Duty of Candour and complaint investigations. She did not believe either process showed a significant investigation was completed to determine how the burns happened. She felt the Trust had just believed what the surgeon said, and the investigations were just an exercise in protecting the surgeon from any wrongdoing.
43. The medical notes taken at the time of (or immediately after) the surgery noted the primary burn as having occurred.
44. The primary burn was raised with the Clinical Director of Breast Surgery at the time of the surgery. They provided the surgeon with guidance on how to treat the primary burn.
45. The Trust initiated a Duty of Candour investigation immediately and classified the incident as moderate harm.
46. The nursing notes indicate the surgeon spoke with Ms E about the primary burn, where he apologised this had occurred. Ms E recalls this was soon after her surgery as she states she was in recovery, but disputes an apology was provided at this time.
47. Ms E raised this issue with the Trust on 17 September 2024 where it classified the complaint as Tier 3. Tier 3 complaints are classified as complex complaints or those requiring a closer look.
48. The Trust began a complaint investigation, speaking to Ms E the next day on the telephone to discuss her issues and followed this up with an email on 19 September. Ms E stated she was unhappy the injury had occurred and felt that she was blamed for this as the surgeon implied that she had sensitive skin. Ms E was unhappy the surgeon did not apologise for the burn.
49. We have noted that whilst the second burn had been included in the records it was not noted until 26 September 2024 after Ms E had visited the Trust for a dressing change to the primary burn.
50. We have seen evidence the Trust was in correspondence with Ms E whilst it investigated the complaint and was undertaking their Duty of Candour. During these discussions Ms E noted that whilst she had received an explanation for the primary burn, she had not received an explanation for the secondary burn. This was added to her complaint points to address. The Trust explained they would expect a complaint response to be issued by the end of February 2025.
51. The Trust issued its Duty of Candour response on 30 September 2024 and responded to the complaint on 10 February 2025. It made references to the medical records and discussions held with the surgery team to draw its conclusions. From a review of both responses, we have seen the Trust provided a response to all the concerns raised.
52. GMC Duty of Candour guidance states discussions about complications should be recorded at the time. It emphasises that when something goes wrong, it is crucial this is documented and communicated.
53. NRLS guidance classifies possible harm in five categories. It defines 'moderate harm' as short term harm requiring further treatment or a procedure and 'severe harm' as permanent or long-term harm.
54. GMC Duty of Candour guidance, says: ‘You should speak to the patient as soon as possible after you realise something has gone wrong with their care…You do not have to wait until the outcome of an investigation to speak to the patient, but you should be clear about what has and has not yet been established… You should share all you know and believe to be true about what went wrong and why, and what the consequences are likely to be… You should apologise to the patient.’
55. It also goes on to state: ‘When something goes wrong with patient care, it is crucial that it is reported at an early stage so that lessons can be learnt quickly and patients can be protected from harm in the future’.
56. Our adviser explained best practice would include a documented follow up conversation or written summary.
57. The GMC Duty of Candour guidance says; ‘Wherever possible, you should first raise your concern with your manager or an appropriate officer… such as the consultant in charge of the team, the clinical or medical director or a practice partner’.
58. Our Principles of Good Complaint Handling say customer-focused public bodies should do the following: ‘Acknowledge the complaint and tell the complainant how long they can expect to wait to receive a reply. Public bodies should keep the complainant regularly informed about progress and the reasons for any delays, and provide a point of contact throughout the course of the complaint.’
59. Our Principles of Good Complaint Handling also say public organisations should be ‘open and accountable.’ This includes providing evidence-based explanations and giving reasons for decisions. It says they should also act ‘fairly and proportionately.’ This includes ensuring complaints are investigated thoroughly and fairly to establish the facts of the case.
60. As part of our investigation, we have also reviewed the Trust’s Complaints Handling Policy which states: ‘We will acknowledge all types of complaints within three working days of receiving them’.
61. After a review of the evidence our adviser stated the classification of 'moderate harm' was appropriate. He noted that whilst scarring may be permanent, it is unlikely this would lead to any permanent or severe damage, noting the burns healed without requiring further surgery.
62. We have seen the Trust acted in line with the Duty of Candour guidance when it documented the primary burn as soon as practicable around the time of the surgery.
63. As discussed above, it was not until later that the secondary burn was identified. We asked our adviser about this. They explained the secondary burn may not have been easily identifiable at the time of the surgery as the area may have been hidden by blood or surgical drapes.
64. We do not find a failing in the Trust’s Duty of Candour in relation to the secondary burn as it appears reasonable the Trust may not have known about it at the time.
65. We note Ms E was spoken to by the surgeon to discuss the burns. It is reasonable to conclude this was soon after the Trust realised there was an issue with the care given that Ms E was in the recovery room at the time. The medical records show the burns were documented in line with Duty of Candour expectations.
66. The evidence shows the surgery team referred this matter to Clinical Director of Breast Surgery whilst the surgery was ongoing so the Trust has abided by its obligations to escalate the concern appropriately within the Trust’s management structure. In the Duty of Candour response, it also detailed the steps taken to ensure that lessons have been learned as a result of Ms E’s experience.
67. Whilst we note there is a dispute that an apology was provided during the initial discussions post-surgery, we can see apologies have been provided in the Duty of Candour and complaint responses.
68. From a review of the actions taken by the Trust when handling the complaint, we find it has followed the relevant points of Our Principles of Good Complaint Handling as well as the Trusts Complaint Handling Policy.
69. The Trust acknowledged the complaint by telephone and email within three working days as it promises. It replied to each of the complaint points and can see its response was based on the clinical records. While we understand Ms E does not agree with some of the content, we believe the Trust answered the substance of Ms E’s concerns in its responses.
70. Whilst we note Ms E is concerned the investigations carried out by the Trust have not been transparent, we have seen the Trust began its Duty of Candour process three days prior to Mrs E raising her complaint. This shows the Trust was following the correct processes even before Ms E made it aware of her dissatisfaction.
71. After careful consideration, we have seen any evidence of service failings in how the Trust handled its Duty of Candour, which covers the communications held immediately after the surgery, or its complaint investigations. We therefore do not consider the Trust’s actions amount to maladministration or service failure.
Conclusion
72. For the reasons outlined above, we will not be taking any further action on Ms E’s complaint about the Trust.
73. We understand this decision may be disappointing for Ms E, especially given the time and effort he has invested. We thank Ms E for bringing his complaint to us and appreciate the opportunity to consider it.