Catalog Number 4203000000 |
Device Problem
Unintended Power Up (1162)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 02/10/2015 |
Event Type
malfunction
|
Event Description
|
It was reported that the handpiece is stuck in on position during inspection before the procedure.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.After receiving at the manufacturer facility it was found that the handpiece was running without pressing the trigger.
|
|
Event Description
|
It was reported that the handpiece is stuck in on position during inspection before the procedure.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.After receiving at the manufacturer facility it was found that the handpiece was running without pressing the trigger.
|
|
Manufacturer Narrative
|
The device has been received, failure analysis is in progress; additional information will be submitted once the quality investigation is completed.Failure analysis is in progress.
|
|
Manufacturer Narrative
|
Device was repaired and returned after passing the final inspection.
|
|
Search Alerts/Recalls
|