It was reported that the scope stem was dented and the distal end was cracked.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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H10: h2, h3, h6.The device, which was not used in a procedure, was returned for evaluation.There was a relationship between the reported event and the device.A visual inspection was performed and showed the scope to have distal tip and fiber damage, a dented outertube and distal lens damage.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found no related failures; this failure mode will be trended to assess for any necessary corrective actions.This failure is confirmed not originate from manufacturing, packaging, or labeling defects.This damage is caused by contact with another source.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.No manufacturing related defects were observed.
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