GUTTAFUSION OBTURATOR OVEN
Received Oct 5, 2018
Report 9611053-2018-00149 · MDR key 7940272
Device
Generic name
Gutta-percha
Manufacturer
Dentsply Vdw GmbhModel number
NACatalog number
V041500000000
Lot number
NA
Product problems
- Unintended Electrical Shock
Patient
Not reported
- No Consequences Or Impact To Patient
- Electric Shock
- No Consequences Or Impact To Patient
- Electric Shock
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATION.
Additional Manufacturer Narrative
WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, IF THIS MALFUNCTION RECURRED, IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.
Description of Event or Problem
IN THIS EVENT IT WAS REPORTED THAT A GUTTA FUSION OVEN, WHEN REMOVING IT FROM THE SOCKET ONLY, HAPPENED TO CAUSE AN ELECTRIC SHOCK; NO INJURY RESULTED.