Model Number URF-V2 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/12/2021 |
Event Type
malfunction
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Event Description
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The customer reported to olympus, the uretero-reno videoscope was leaking during reprocessing.Another uretero-reno videoscope was used to complete the following procedure.During the inspection of the returned device, the cable support was broken and protruding from the bending section cover.There were no reports of patient harm associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
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Manufacturer Narrative
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The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.The device was leaking around the rubber on the distal end.The cable support was broken and protruding from the bending section cover.The raised part of the cable support caused a perforation of the bending section rubber cover, which had caused the leak.In addition, a case on the scope was slightly scratched.The investigation is ongoing and a supplemental report will be submitted upon completion of the investigation.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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.Based on the results of the investigation, it is likely an excessive force was applied to the bending section, which damaged the bending tube.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.
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Search Alerts/Recalls
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