The reported device, intended for use 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 damage, fiber damage, a cracked distal lens, and moisture. 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 the set-up of an unknown procedure, the scope was cloudy.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.Results of investigation have concluded that this unit had a cracked distal lens which makes it a reportable event.
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