Model Number URF-V |
Device Problem
Failure to Clean Adequately (4048)
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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 returned to olympus for evaluation and a foreign instrument blocked the biopsy channel.The biopsy channel was leaking, the distal end cover was damaged, the bending section glue was chipped, and the insertion part of the bending section cover was worn.The connecting tube and parts of the control unit (grip unit, up/down plate and lever unit) were scratched.The universal cord was scratched and wrinkled.The video cord and scope connector were both scratched.The device also failed the angle inspection.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
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Event Description
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The customer reported to olympus, there was an air/ water or aspiration issue observed on the videoscope prior to an unknown procedure.During the inspection of the returned device, a foreign instrument blocked the biopsy channel, which had been attributed to insufficient cleaning.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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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.Based on the results of the legal manufacturer's investigation and based on the air leak from the biopsy channel, it was determined that a foreign material was likely clogged inside the biopsy channel possibly due to the device being improperly cleaned.However, there was no detailed information on the foreign material and image, hence, the cause of the issue could not be specifically identified.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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