Model Number URF-P6 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 08/28/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
The subject device was returned to omsc for evaluation.The exact cause has been under investigation, therefore 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
|
Olympus medical systems corp.(omsc) was informed from the user that the black cylindrical foreign object came out from the distal end of the subject device at the reprocessing after the transurethral lithotripsy.The procedure before the reprocess had been completed without any problem.It was not provided other detailed information such as the reprocessing method.There was no report of patient injury associated with this event.
|
|
Manufacturer Narrative
|
The subject device and the black cylindrical foreign object were returned to olympus medical systems corp.(omsc) for the evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Omsc checked the subject device and found that there was no water leakage.Since omsc has no clue that how the user use the subject device at the facility, the exact cause of the reported event could not be conclusively determined.However omsc could check the black cylindrical foreign object, it was not derived from the subject device but it might have been the endotherapy instruments and so on which the user use at the facility.If additional information becomes available, this report will be supplemented.
|
|
Search Alerts/Recalls
|