|
Model Number CCU, ARTHREX SYNERGY UHD4 |
Device Problem
Fire (1245)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/25/2022 |
Event Type
malfunction
|
Event Description
|
On (b)(6) 2022 it was reported by a sales representative via sems that an ar-3200-0021 synergy console had a heat issue.The light source was turned on while not connected to a scope.The light cord was sitting on a drape and the drape caught on fire.
|
|
Manufacturer Narrative
|
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
|
|
Search Alerts/Recalls
|
|
|