Model Number CYF-VH |
Device Problem
Break (1069)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 09/24/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device was returned to olympus for evaluation.During the evaluation, the scope did not pass the leak test.The reported issue was confirmed, the insertion tube sheath was damaged exposing the metal mesh.The light guide tube had minor dents and scratches.No other issues were found during the inspection.If additional information is provided a supplemental report will be filed.
|
|
Event Description
|
A user facility reported a videoscope with a broken bending rubber and the metal sticking out close to where the cord is located.The issue was found during reprocessing of the device.There was no patient involvement or injuries.No additional information has been obtained.
|
|
Manufacturer Narrative
|
Upon further review of the reported issue, it was determined that this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.
|
|
Search Alerts/Recalls
|