|
Model Number WA50040A |
Device Problem
Output Problem (3005)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/18/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
To date, the device has not been returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
|
|
Event Description
|
The customer reported to olympus that the video telescope "endoeye hd ii", 10 mm, 0°, autoclavable had a green or purple image with stripes in the image.The issue was found during the therapeutic procedure that was completed with a similar device and no delay.There were no reports of patient harm.
|
|
Manufacturer Narrative
|
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct d9.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, the root cause of the event could not be determined although it can be presumed that the event occurred due to camera control unit plug and charge coupled device degradation.Olympus will continue to monitor field performance for this device.
|
|
Search Alerts/Recalls
|
|
|