FDA Adverse Event
Malfunction
Summary report: N
LAPAROSCOPIC GRASPER
MDR report key: 20256
·
Received March 14, 1995
Report
- Report Number
- MW1005431
- Event Type
- Malfunction
- Date Received
- March 14, 1995
- Date of Event
- March 3, 1995
- Report Date
- March 13, 1995
- Manufacturer
- CABOT MEDICAL CORP.
- Product Code
- GEN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE RPTR STATED THAT DURING A PROCEDURE A 1/2 INCH PIECE OF THE LONG GRIPPER BROKE OFF, REQUIRING AN OPEN PROCEDURE TO RETRIEVE THE PIECE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAPAROSCOPIC GRASPER | GEN | CABOT MEDICAL CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR |