H10: h3,h6: 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 scratched distal lens, and broken lenses.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 an repeat event.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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