|
Model Number A22002A |
Device Problem
Crack (1135)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/27/2023 |
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 additional information is provided by the user facility.
|
|
Event Description
|
The customer reported to olympus, the telescope, 30°, 4 mm had a cracked lens.The issue was found during reprocessing.There were no reports of patient harm.
|
|
Search Alerts/Recalls
|
|
|