CONMED
Received Dec 21, 2009 · Event occurred Oct 27, 2009
Report 1720159-2009-00048 · MDR key 1575149
Device
Generic name
Argon Beam Coagulation, Nozzle
Manufacturer
Conmed ElectrosurgeryCatalog number
138030
Lot number
UNK
Product problems
- Detachment Of Device Component
- Loose or Intermittent Connection
Patient
Not reported
- Perforation
- Pneumothorax
Narrative
Description of Event or Problem
THE PT WAS UNDERGOING A LIVER TRANSPLANT. THE SURGEON WAS USING A CONMED ABC-ARGON BEAM COAGULATOR. THE TIPS ARE DISPOSABLE AND THE CORD IS GOOD FOR 100 USES ACCORDING TO THE MFR. IT APPEARS ON THIS OCCASION THAT THE METAL INSERT WHICH DOES NOT PROTRUDE BEYOND THE PT END HAD SOMEHOW BECOME LOOSE INSIDE THE CARRIER. WHEN THE GAS WAS APPLIED, THE METAL PIECE WAS SHOT OUT WITH SOME FORCE. THE METAL PIECE PUNCTURED THE PLEURAL SPACE THROUGH THE DIAPHRAM CAUSING A PNEUMOTHORAX AND REQUIRING A CHEST TUBE.
Additional Manufacturer Narrative
CONMED ELECTROSURGERY HAS MADE SEVERAL ATTEMPTS TO CONTACT THE INITIAL REPORTER. WE HAVE HAD NO REPLY TO OUR ATTEMPTS TO OBTAIN THE SUSPECT DEVICE FOR EVAL.