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.The subject device was returned to an olympus service center for evaluation.Upon inspection and testing of the returned device, the customer's complaint was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.Based on the results of the legal manufacturer's investigation, although a conclusive root cause could not be determined, it is likely the forceps could not be inserted or removed due to following: the event occurred due to deformation of the forceps channel.The event occurred due to breakage of the instrument.The event occurred due to foreign material in the forceps channel.The following information is stated in the ifu (instructions for use) which may help to prevent the issue: 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.Olympus will continue to monitor field performance for this device.
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