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Model Number CHF-CB30L |
Device Problem
Peeled/Delaminated (1454)
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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 subject device was returned to olympus for evaluation.During inspection and testing, the allegation was not confirmed.In addition to the finds reported in event, due to a pinhole on bending section cover, water tightness was lost.Due to a pinhole on connecting tube, water tightness was lost.Due to a pinhole on channel tube, water tightness was lost.Connecting tube had a dent.Due to wear of angle wire, bending angle in up direction did not meet the standard value.The image guide bundle had significant breakages.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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An olympus employee reported a pinhole in the bending section cover of a loaner asset, oes choledochofiberscope.There was no report of user or patient harm associated with this event.During incoming inspection, it was determined the image guide coil coating was peeling.This medwatch 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.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely the coating of the insertion tube peeled due to stress of repeated use, external factors, or handling.The root cause of this event was unable to be identified.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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