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Model Number HYF-V |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The device was evaluated at olympus and the customer's allegation was confirmed.The device evaluation found the forceps channel port was shaved and due to a cut distal sheath end, water tightness was lost.Additionally, the device evaluation revealed connecting tube had a dent, the video connector case, video cable and universal cord were dirty.Also, the video connector case had a crack.Scratches were also found on the following device components: video connector case, light guide connector, video cable, universal cord, lock engagement lever, up/down plate, angulation lever, grip, switch box and control unit.Additional information has been requested regarding this event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
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Event Description
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The customer reported to olympus that while using the visera hysterovideoscope, the distal sheath end was found to be cut.There was no patient harm associated with the event.The device was returned and evaluated, and the forceps plug mouthpiece is scraped off.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.
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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 more than 5 years, since the subject device was manufactured.Based on the results of the investigation, it could not be determined, if the scraped instrument channel port was caused by load, handling, or other issues.Therefore, the root cause could not be determined.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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