A nurse reported that during a pars plana vitrectomy and membranectomy with laser procedure, the trocar cannula was leaky and it was difficult to remove instruments without the trocar coming out with the instrument.The trocar was replaced with a standalone valved entry system, however the same issue occurred.Another standalone valved entry system was used to complete the case.There was no harm to the patient.No sample is available as the customer discarded the products.There are two related reports for this patient; this report is for the issue with the standalone valved entry system.
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No samples were returned for evaluation; therefore, the condition of the product could not be verified.The device history record (dhr) for the lots were reviewed.No abnormalities that could have contributed to the reported complaint were found during the dhr review and the product ws released according to the manufacturer's acceptance criteria.Because a sample was not returned and no evidence of nonconformity that could have caused the complaint could be found in the lot record review, the root cause for the customer complaint issue cannot be determined.(b)(4).
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