CONMED
Received Jul 14, 2010 · Event occurred May 28, 2010
Report 1720159-2010-00048 · MDR key 1760672
Device
Generic name
Argon Beam Coagulation Handpiece
Manufacturer
Conmed ElectrosurgeryCatalog number
130321
Lot number
0908133
Product problems
- Self-Activation or Keying
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
CONMED ELECTROSURGERY RECEIVED ONE ABC TRIPLE OPTION HANDPIECE FOR EVALUATION. DURING OUR EVALUATION, THE SUSPECT DEVICE SELF ACTIVATED.
Additional Manufacturer Narrative
OUR INVESTIGATION TEAM FOUND THE COAG BUTTON TO SELF ACTIVATE WHEN PLUGGED INTO THE ESU DURING TESTING. WE DISSECTED THE HANDPIECE AND FOUND NO IRREGULARITIES. OUR EVALUATION CONTINUED BY STRIPPING THE SUPPLY WIRE/CABLE TO PERFORM CONTINUITY TESTING. IT WAS OBSERVED, THE RED WIRE AND THE BLACK WIRE OF THE SUPPLY WIRE/CABLE TO BE SHORTED CAUSING THE SELF ACTIVATION. THE REPORTED MALFUNCTION WAS CONFIRMED. MANUFACTURING FACILITY WAS MADE AWARE REGARDING THIS COMPLAINT. OUR MANUFACTURING FACILITY WAS MADE AWARE OF THIS CONFIRMED EVENT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WHICH REVEALED NO NONCONFORMANCES.