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.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 that due to clogging of the instrument channel, forceps and brush could not be passed through the channel, and the forceps elevator could not be adjusted to specifications.In addition, the catheter movement was too light, and the guidewire tension was not smooth, due to the clogging of the channel.A leak was also observed between the control body and cover.There were dents and scratches on the distal end cover and control body.The rubber adhesive was cracking.The light guide lens was cracked.The insertion tube had excessive buckling.The angulation was low, and the up/down control knob had play.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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