Model Number CLV-190 |
Device Problem
Application Program Problem (2880)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The device was not returned to olympus medical systems corp.(omsc), but returned to olympus repair center for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
|
|
Event Description
|
During the preparation for use, the user found that error e103 (clv lamp error) was displayed.There was no report of patient injury associated with this event.The user facility did not provide other detailed information.
|
|
Manufacturer Narrative
|
This supplemental report is being submitted to provide additional information.The device was returned to olympus repair center, but not returned to olympus medical systems corp.(omsc).Therefore, omsc could not confirm the device.Olympus repair center could confirm the reported phenomenon.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Omsc surmised that the service life of the lamp has expired or the incidental malfunction occurred.If significant additional information is received, this report will be supplemented.
|
|
Search Alerts/Recalls
|