The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident. a visual inspection found deep distal tip and fiber damage and a scratched and cracked distal lens.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution. a complaint history review concluded this was a repeat issue.The complaint was confirmed.Factors that could have contributed to the reported event include an impact event inconsistent with normal use.Internal complaint reference: (b)(4).
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It was reported that during a knee scope procedure, the scope was found scratched, backup device was available to complete the procedure with no surgical delay.No patient injuries were reported.Results of investigation have concluded that this unit had a cracked distal lens which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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