The subject device was returned to an olympus service center with no complaint, and no patient or user injury was reported.During inspection and testing, service found the forceps could not be inserted/removed due to clogging of the instrument channel with foreign material.This report is being submitted for the malfunction found during the evaluation.
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This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a definitive root cause could not be determined.The event can be detected/prevented by following the instructions for use: ·operation manual 3.8 inspection of the endoscopic system - inspection of the instrument channel and forceps elevator ·operation manual important information ¿ please read before use - precautions ·operation manual 3.6.Inspection of ancillary equipment ·operation manual 4.3.Using endotherapy accessories ·reprocessing manual 5.Reprocessing the endoscope (and related reprocessing accessories) ·reprocessing manual 7.Reprocessing endoscopes and accessories using an aer/wd during the device evaluation, service found a deep dent on the hold ring, a scratch on the distal end cap (c-cover), and the rubber adhesive was cracked, and the customer label was worn.Per the legal manufacturer, this issue identified by service has no potential to cause or contribute to death or serious injury if the malfunction was to recur.Olympus will continue to monitor field performance for this device.
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