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 3 years since the subject device was manufactured.During inspection and testing, service confirmed the customer¿s reported issue, and found there was no suction due to the clogged biopsy channel.Based on the results of the investigation, the possible causes for the event could have been due to deformation of the forceps/biopsy channel, breakage of the instrument, or foreign material in the forceps/biopsy channel.However, a definitive root cause could not be determined.The event may be detected by following the instructions for use which state: ·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.Service was unable to perform a leak test due to the clogged biopsy/forceps channel.The guide wire tension was not smooth and was unable to check due to the clogged biopsy channel.The catheter movement was too light and unable to check the test due to the clogged biopsy channel.Dents and scratches were observed on the distal end plastic cover and control body.The rubber covering (a-rubber) adhesive on the insertion tube and distal cover was cracked.The right/left up/down control knobs were loose and 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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The customer reported that during an unspecified procedure using the subject device, the user was unable to pass wire or instruments through the biopsy channel, there is hitting resistance.There was no patient or user injury reported due to the event.No further information was provided.
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