Model Number CLV-260 |
Device Problem
Electrical /Electronic Property Problem (1198)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/20/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
The suspect device was returned to olympus and evaluated.The reported problem was not confirmed.However, it was noted that the bulb was a non-olympus bulb.The investigation is ongoing and the conclusive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
|
|
Event Description
|
A user facility reported to olympus that the bulb was "burnt." the problem, as reported to olympus, was identified during reprocessing.There was no patient injury, associated with the problem, reported to olympus.
|
|
Manufacturer Narrative
|
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct information provided on the initial report.The following sections were corrected: d8.It has been over 14 years since the subject device was manufactured.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the legal manufacturer's investigation, the phenomenon of ¿lighting failure of the lamp¿ was not confirmed, however, the reported issue seemed to have occurred because a non-olympus lamp was used.The instruction manual identifies the following related verbiage which could have prevented the phenomenon: ¿use the examination lamp md-631 only.¿ olympus will continue to monitor field performance for this device.
|
|
Search Alerts/Recalls
|
|