FDA Adverse Event
Malfunction
Summary report: N
BABCOCK FORCEPS, ROTO-LOK, LOCKING LEVER, 5MM, 3
MDR report key: 924869
·
Received October 4, 2007
Report
- Report Number
- 2430952-2007-00044
- Event Type
- Malfunction
- Date Received
- October 4, 2007
- Report Date
- October 4, 2007
- Manufacturer
- KOSCHER & WUERTZ GMBH
- Product Code
- GEN
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- MO, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
THE USER FACILITY REPORTED THAT THE DEVICE WAS INVOLVED IN A PERFORATED (RUPTURED) ILIUM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BABCOCK FORCEPS, ROTO-LOK, LOCKING LEVER, 5MM, 3 | ENDOSCOPIC INSTRUMENT | GEN | KOSCHER & WUERTZ GMBH | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |