FDA Adverse Event
Other
Summary report: N
REDDICK OLSEN FORCEPS
MDR report key: 443187
·
Received February 5, 2003
Report
- Report Number
- 443187
- Event Type
- Other
- Date Received
- February 5, 2003
- Date of Event
- September 17, 2002
- Report Date
- December 16, 2002
- Manufacturer
- KARL STORZ ENDOSCOPY-AMERICA, INC
- Product Code
- GEN
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MD, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
A SURGEON WAS USING THE LAPAROSCOPIC GRASPER DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE TIP OF THE GRASPER BROKE OFF IN THE PT AND WAS UNABLE TO BE RETRIEVED BY THE SURGEON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REDDICK OLSEN FORCEPS | LAPAROSCOPIC GRASPING FORCEPS | GEN | KARL STORZ ENDOSCOPY-AMERICA, INC | 3331OU1 | IM3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |