It was reported that, during setup of the procedure, the scope had a crack in the tip lens.It is unknown when the event occurred or if there was a backup device available.No delay nor patient injury reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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H10 h3,h6: 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 dent needle, bent needle, distal tip and fiber damage, broken lenses, sidearm cone damage and compact lens damage.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.
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