Model Number CYF-5 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/10/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned to olympus for evaluation.During the evaluation, a leak was confirmed.The plastic cover body was found with minor scratches.The forceps passage contained tear and scrape marks inside.A piece of plastic was found on the brush passage while cleaning it.The insertion tube contained minor surface scratches as well as the eyepiece body.No other issues were found during the device inspection.If additional information is obtained a supplemental report will be filed.
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Event Description
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A user facility reported that the distal end of the scope's bending section covering ruptured.There was no patient involvement or injuries reported.No additional information has been obtained.
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Manufacturer Narrative
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The investigation has been completed.A device history record (dhr) review was performed and found no non-conformance that would cause the reported malfunction.All records indicate that the device was manufactured in accordance with all applicable procedures.The root cause could not be conclusively determined.Probable causes that could have led to the reported event include some kind of impact was applied and parts (piece of plastic) on the accessories side may have entered the port.
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Search Alerts/Recalls
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