It was reported that the videoscope exhibited occurrences where parts fell off from the distal end, including a rubber component.Additionally, the coating on the tip of the scope came off.The event was found during reprocessing.There were no reports of patient involvement.
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This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's allegation was confirmed.Based on the results of the investigation, for the event coating on the insertion section peeled off, it is surmised that while the user was handling the device the application of chemical stress on the insertion section, lead to the event.Regarding the event of chemical damage to the insertion section, it is likely that while the user was handling the device, the insertion section experienced chemical damage, leading to the exposure of internal metal at the insertion section.The events can be detected by following the instructions for use: -inspection of the endoscope.Olympus will continue to monitor field performance for this device.
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