Internal complaint reference (b)(4).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 distal tip and fiber damage, a cracked distal lens, and scratches on the needle. 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.No containment or corrective actions are recommended at this time.
|