|
Model Number A22001A |
Device Problems
Corroded (1131); Scratched Material (3020)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
It was observed during the device inspection, that the telescope exhibited scratches on the tip objective lens and there was corrosion on the insertion part outer tube.There were no reports of patient involvement.
|
|
Manufacturer Narrative
|
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Manufacturer Narrative
|
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following fields:h6, h11.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 14 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that scratches on the tip objective lens and there was corrosion on the insertion part outer tube occurred due to an excessive force applied to the distal end of the telescope as a result of an impact or a shock and moisture from a leak by poor or faulty preparation.Olympus will continue to monitor field performance for this device.
|
|
Search Alerts/Recalls
|
|
|