Equipment used during pre-operative assessment
14. Before we decide if we should conduct a detailed investigation of a complaint, we look at whether there are signs the organisation has got something wrong. We do this by comparing what should have happened with what did happen. We have done this and have not found any indications that something has gone wrong.
15. Mr C complained that when he attended a pre-operative assessment, the light was not working on the equipment when staff tried to examine his eye. He said they did the examination using a light on the consultant’s head. We recognise it was worrying for Mr C when staff had to use different equipment than planned to examine his eye.
16. In the complaint response 15 July 2024, the Trust explained the slit lamp (a tool used to microscopically examine the inside of the eye) had a blown bulb which was awaiting a replacement to be delivered and installed. In the meantime, surgeons were using a binocular indirect ophthalmoscope (an optical instrument worn on the examiner’s head that is also used to examine the inside of the eye). The Trust said both instruments were clinically appropriate to perform pre-operative checks.
17. According to the medical records, Mr C had a pre-operative assessment on 12 July 2022 when he was listed for cataract surgery to his right eye. This included a full examination of the eye using a slit lamp, the eye pressure was tested, and a dilated retinal examination was undertaken and determined to be normal. Our clinical adviser said this pre-operative assessment was comprehensive and used appropriate equipment.
18. It is not documented what equipment the Trust used to examine Mr C immediately before his cataract surgery on 10 August. Our clinical adviser said there is no indication from the records that any of the equipment was malfunctioning or inappropriate on the day of the surgery.
19. The medical records show the Trust completed a pre-operative checklist and an intra-operative care plan on 10 August 2022, and no issues were raised.
20. We hope Mr C is reassured we cannot see any indications of failings with the equipment used to complete pre-operative checks before Mr C’s operation on 10 August 2022.
Equipment used during operation
21. Mr C complains that during his operation he heard staff talking about a piece of equipment not working when plugged into the usual socket in the operating room. He also heard staff talking about other equipment not working properly. We recognise it was worrying to hear staff talking about this.
22. In the complaint response 15 July 2024, the Trust said a piece of equipment initially did not work on 10 August 2022 but was fully operational after it was plugged into a different socket.
23. Our clinical advisor said the surgery was performed using appropriate equipment and there is there is no mention of any malfunction of equipment. According to the medical records, the procedure debrief document shows there were no safety issues raised during the operation.
24. GMC Good Medical Practice says if patients are at risk because of inadequate premises, equipment or other resources, policies or systems, doctors should put the matter right if that is possible.
25. According to the complaint response from the Trust, the medical records and clinical advice, the Trust staff did follow guidance regarding the equipment issue on 10 August and promptly put it right by plugging the device into another socket. We hope Mr C is reassured we have seen no evidence the Trust used malfunctioning equipment during his surgery.
Complications during operation
26. Mr C complained that during the operation staff pierced his retina and gel escaped from his eye. We understand how worrying it was for Mr C to learn there had been complications during his surgery.
27. In the complaint response 15 July 2024, the Trust said Mr C’s retina was not pierced. The Trust said the surgery was complicated by a posterior capsule rupture (a tear in the capsule of the lens) and gel escaped from the eye. The Trust said this is a known complication of cataract surgery and is listed on the consent form.
28. We can see the consent form Mr C signed indicates that a posterior capsule rupture and a vitreous (gel) loss can occur during surgery. Our Adviser noted the consent form could have been clearer in stating this complication may lead to further surgery being required.
29. Though the consent form does mention the risk of further surgery for a different complication, it should also be mentioned as a potential outcome of posterior capsule rupture and vitreous loss. We have informed the Trust of our view on this and asked it to review the consent form and make it clearer for future patients.
30. Our clinical advisor said there is no evidence from the records that the surgery on was not carried out appropriately. Our adviser confirmed the notes show the surgery was complicated by posterior capsule rupture following implantation of the lens.
31. Our adviser confirmed posterior capsule rupture is a recognised complication of cataract surgery. We can see this is also set out as a recognised complication in NICE cataract guidance.
32. Our clinical advisor said there was no evidence of any additional piercing of the eye other than the incisions that would be necessary during a routine cataract operation without complications. Our adviser explained the vitreous (gel) moved into the back part of the eye as a result of the posterior capsule rupture and required management to limit other complications from occurring.
33. The records show that after the posterior capsule rupture the Trust carried out an anterior vitrectomy (procedure to remove vitreous gel from the back part of the eye). Our Adviser said this was in line with good practice.
34. We can see no indications of any failings as there was no piercing of the retina, and the complications that occurred were recognised complications of cataract surgery.
Communication about anaesthetic for revision surgery
35. Mr C complains that when the Trust told him he would need revision surgery, it incorrectly told him this would be done under a local anaesthetic. He said staff did not advise him he needed to fast before surgery. Mr C said when he attended for the revision surgery the anaesthetist said it would need to be done under a general anaesthetic. As Mr C had eaten breakfast, the surgery had to be rescheduled for a later date.
36. In the complaint response of 15 July 2024, the Trust said it was agreed that the revision surgery would be under general anaesthetic but was not explicit about when this was communicated to Mr C.
37. The Trust also said during the pre-operative assessment on 2 September 2022, the doctor informed Mr C the surgery would take longer than the previous operation. The Trust said it was agreed that it would be in Mr C’s best interest to have this surgery performed under general anaesthetic rather than local anaesthetic to achieve an optimal outcome.
38. The medical records show at the appointment on 19 August 2022, it was planned for local anaesthetic to be used in the revision surgery. They also show at the appointment on 26 August 2022, ‘topical’ (local) anaesthetic was planned for the revision surgery.
39. The medical records for 2 September 2022 say Mr C told staff he felt it would not be suitable for him to have local anaesthetic due to the time length of the surgery. The doctor told Mr C he could not have general anaesthetic that day as he had eaten that morning. The doctor noted it was safe to defer the surgery until November.
40. We have three conflicting accounts of what happened. We have Mr C’s account that he was always told the procedure would be done under local anaesthetic, then the anaesthetist said on the day it would be general anaesthetic.
41. We also have the Trust’s response that it had told Mr C it would be done under general anaesthetic but did not specify when this was communicated to him.
42. We also have the clinical records which document the plan was for a local anaesthetic, but Mr C changed his mind on the day and opted to have general anaesthetic at a later date.
43. We carefully weighed up these accounts to reach a view on the balance of probabilities on what happened. As the medical records were written at the time of these events and are detailed, these are a very strong source of evidence. These also align with some of Mr C’s account that the plan was for the procedure to be done under local anaesthetic. It is reasonable to say that on the balance of probabilities, it is most likely that the Trust planned to do the surgery under local anaesthetic.
44. It appears likely that as set out in the clinical records, Mr C decided to opt for general anaesthetic on the day of the surgery when staff discussed the length of the operation with him.
45. GMC Good Medical Practice 2013 says doctors must give patients the information they want or need to know in a way they can understand. In this case, doctors should have told Mr C what anaesthetic they planned to use and any necessary instructions for this, such as fasting.
46. As we think it is most likely staff told Mr C the surgery would be under local anaesthetic, the doctors would not have been required to tell him to fast prior to the surgery. We have seen no indications the Trust did anything wrong in terms of communicating about the anaesthetic or fasting requirements for the revision surgery.
47. We thank Mr C for bringing this complaint to us. We understand Mr C went through a very worrying time when he had complications during cataract surgery and required revision surgery. We understand the stress and pain this caused and the impact on his daily life. We also recognise that Mr C continues to have problems with his sight in one eye following his treatment. We hope our explanation provides Mr C some reassurance on what happened during the treatment for his eye, and that we have seen no evidence the Trust did anything wrong.