MalfunctionFLF
ULTRACISION HARMONIC SCALPEL HAND PIECE
Received Aug 4, 2008
Report 1527736-2008-03846 · MDR key 1085046
Device
Product problems
- Changes In Ambient Temperature In Device Environment
- Device Displays Incorrect Message
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
INFO NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
Description of Event or Problem
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE HANDPIECE REC'D AN OVERTEMPERATURE ERROR. IT WASN'T KNOWN HOW THE CASE WAS COMPLETED BUT THERE WAS NO CONSEQUENCE TO THE PATIENT.