|
Model Number A22001A |
Device Problems
Break (1069); Disconnection (1171)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
It was reported to olympus that telescope was sent in for repair due to damage to the camera head connection.It is unknown when the reported issue was found.There was no patient injury or adverse event reported to olympus.
|
|
Manufacturer Narrative
|
The device was returned to olympus for evaluation and repair.The investigation is still in progress; therefore, the root cause of the reported defect cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.In general, the customer is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.Olympus will continue to monitor the field performance of this device.
|
|
Manufacturer Narrative
|
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned to olympus and evaluated, and the eye piece damage was confirmed.The device was returned to olympus and evaluated, and the reported issue with the damaged eye piece was user error, improper handling and application of excessive force.Olympus will continue to monitor field performance for this device.
|
|
Search Alerts/Recalls
|
|
|