Model Number TJF-Q180V |
Device Problem
Contamination /Decontamination Problem (2895)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 11/04/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
|
|
Event Description
|
A customer reported that there was a leak from the bending section of the device during reprocessing before use.And it was found that foreign matter adhered to the gap at the distal end of the device.There was no report of patient injury associated with this event.
|
|
Manufacturer Narrative
|
This supplemental report is being submitted to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, based upon the information from olympus india, there was the possibility that the reported phenomenon was attributed to the improper reprocessing of the subject device by the user.
|
|
Search Alerts/Recalls
|