FDA Adverse Event
Malfunction
Summary report: N
AESCULAP PRESTIGE
MDR report key: 1870625
·
Received October 2, 2010
Report
- Report Number
- MW5017714
- Event Type
- Malfunction
- Date Received
- October 2, 2010
- Date of Event
- September 22, 2010
- Report Date
- October 1, 2010
- Manufacturer
- B BRAUN
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING PROCEDURE LAPAROSCOPIC GRASPER JAW BROKE OFF INSIDE THE ABDOMEN OF THE PT. PIECE WAS RETRIEVED, NO HARM TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AESCULAP PRESTIGE | LAPAROSCOPIC 5MM ACTION GRASPER (FRENCH FRY GRASPER) | GCJ | B BRAUN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR |