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.It has been over 7 years since the subject device was manufactured.During the inspection and testing of the returned device, service could not confirm the customer¿s reported issue.Based on the results of the investigation, a definitive root cause could not be determined.However, the following are the potential causes: deformation of the forceps channel.Breakage of the instrument.Foreign material in the forceps channel.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 the adhesive on the curved rubber was cracked.The angle of the curvature was insufficient due to elongation of the angle wire.The angle knob play was out of specification due to stretching of the angle wire.Scratches were observed on the forceps channel, on the insertion tube, on the insertion tube boot, on switch 1, on switch 3, on switch 4, on the operation side of the universal cord, and on the scope connector side of the universal cord.Per the legal manufacturer, these other device issues identified by service have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.Olympus will continue to monitor field performance for this device.
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