H10.H2, h3, h6: the device, which was 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 a cracked negative lens.This failure is confirmed not originate from manufacturing, packaging, or labeling defects.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.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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