FDA Adverse Event
Malfunction
Summary report: N
GU BOVIE CORD
MDR report key: 3594515
·
Received January 10, 2014
Report
- Report Number
- 3594515
- Event Type
- Malfunction
- Date Received
- January 10, 2014
- Date of Event
- December 20, 2013
- Report Date
- January 10, 2014
- Manufacturer
- WILL PROVIDE
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
GU SURGICAL PENCIL STARTED SMOKING WHERE CORD AND INSTRUMENT FORCEPS MEET. THEN BROKE OFF. REPLACED INSTRUMENT; NO HARM TO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 20592 | GU BOVIE CORD | CORD, ELECTRIC, FOR ENDOSCOPE | GEI | WILL PROVIDE | * | * | |
| 20593 | GU BOVIE FORCEP | FORCEPS, GENERAL & PLASTIC SURGERY | GEN | WILL PROVIDE | * | * | |
| 20594 | ARGON BEAM | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | WILL PROVIDE | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR |