|
Model Number URF-P7 |
Device Problem
Loose or Intermittent Connection (1371)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
A user facility returned the olympus asset, uretero-reno fiberscope, to the olympus service center.Upon inspection and testing of the returned device, it was observed that the forceps channel port is shaved.This report is being submitted for the event found during evaluation.There was no patient involvement.
|
|
Manufacturer Narrative
|
The device was returned to olympus for evaluation.The device evaluation found a dent on distal end, loss of water tightness, the forceps channel port is shaved, the eyepiece has a scratch, and the control unit has discoloration.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
|
|
Manufacturer Narrative
|
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.Based on the results of the investigation, it is likely that the reportable event occurred by stress of repeated use, external factors or handling of the device.Olympus will continue to monitor field performance for this device.
|
|
Search Alerts/Recalls
|
|
|