FDA Adverse Event
Injury
Summary report: N
PROTEGE
MDR report key: 18018
·
Received November 29, 1994
Report
- Report Number
- MW1004183
- Event Type
- Injury
- Date Received
- November 29, 1994
- Date of Event
- November 1, 1994
- Report Date
- November 11, 1994
- Manufacturer
- DAVIS & GECK, INC.
- Product Code
- GEN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
GRASPER BROKE DURING LAPAROSCOPY, AND SURGICAL PROCEDURE CONVERTED TO OPEN LAPAROTOMY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTEGE | GRASPER | GEN | DAVIS & GECK, INC. | PROTEGE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Hospitalization |