Model Number SYNERGY RESECTION SHAVER CONSOLE |
Device Problem
Device Emits Odor (1425)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/08/2024 |
Event Type
malfunction
|
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.
|
|
Event Description
|
It was reported that during shoulder surgery a "popping" sound was heard, a burning smell was noticed and the device shut off.It was further reported that the event occurred after 9 minutes.The device itself was unpacked and connected prior to this surgery.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
|
|
Search Alerts/Recalls
|