FDA Adverse Event
Malfunction
Summary report: N
EVEREST BIPOLAR BICOAG LP SCISSORS
MDR report key: 1081153
·
Received July 15, 2008
Report
- Report Number
- 1081153
- Event Type
- Malfunction
- Date Received
- July 15, 2008
- Date of Event
- July 14, 2008
- Report Date
- July 15, 2008
- Manufacturer
- GYRUS MEDICAL, INC
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PHYSICIAN WAS USING SCISSORS DURING A DIAGNOSTIC LAPAROSCOPY. TRYING TO REMOVE A SUTURE FROM A PREVIOUS SURGERY AND SCISSORS MADE A "SNAP" SOUND AND WOULD NOT CLOSE. SCISSORS REMOVED FROM PATIENT AND NOT USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EVEREST BIPOLAR BICOAG LP SCISSORS | FORCEPS, ESU, BIPOLAR | GEI | GYRUS MEDICAL, INC | * | 7107065 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |