FDA Adverse Event
Malfunction
Summary report: N
CONMED ELECTROSURGICAL PENCIL WITH ARGON BEAM COAGULATION
MDR report key: 297629
·
Received September 19, 2000
Report
- Report Number
- 1720159-2000-00074
- Event Type
- Malfunction
- Date Received
- September 19, 2000
- Date of Event
- August 1, 2000
- Report Date
- August 22, 2000
- Manufacturer
- CONMED/ASPEN LABS
- Product Code
- GEI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A SERIOUS INCIDENT HAPPENED TWICE AT A HOSPITAL FOR TRANSPLANTS. WHILE USING ARGON BEAM AT MID POWER (60/80 WATT), THE CONDUCTIVE NEEDLE INSIDE THE NOZZLE OF THE ABC PENCIL, 130322, WAS EJECTED IN THE OPERATING FIELD. THERE WAS NO HARM TO THE PT EITHER TIME. THIS REPORT IS FOR THE EVENT THAT HAPPENED AT THE BEGINNING OF AUGUST. FOR THE EVENT THAT HAPPENED THE LATTER PART OF AUGUST REFER TO 1720159-2000-00075.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONMED ELECTROSURGICAL PENCIL WITH ARGON BEAM COAGULATION | ELECTROSURGICAL PENCIL WITH ARGON BEAM COAGULATION | GEI | CONMED/ASPEN LABS | ABC HANDPIECE | 9906141 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | CONMED'S SYSTEM 6500 ABC ESU, #136065. |