Model Number CLV-S40PRO |
Device Problem
Defective Device (2588)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The device has not returned to olympus medical systems corp.(omsc) for evaluation.There were no further details provided.If significant additional information is received, this report will be supplemented.
|
|
Event Description
|
Olympus service operation repair center was informed from the facility that while the user was using otv-s7pro and clv-s40pro, the front panel display of the clv-s40pro blinked.Other detailed information was not provided.There was no report of patient injury associated with the event.This is a report for clv-s40pro.
|
|
Manufacturer Narrative
|
This supplemental report is being submitted to provide additional information.The device was returned to olympus service operation repair center (sorc) but not returned to olympus medical systems corp.(omsc).Sorc checked the device and found that the reported phenomenon was duplicated.Omsc could not investigate the device, because the device was not returned to omsc.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.Since the device was not returned to omsc, the exact cause was unknown.As about 10 years has passed since the manufacture date of the device, omsc surmised that the reported phenomenon occurred due to the front panel unit or the internal parts of the device were broken by aging degradation.
|
|
Search Alerts/Recalls
|