FDA Adverse Event
Injury
Summary report: N
ATRAUMATIC GRASPERS
MDR report key: 134213
·
Received November 19, 1997
Report
- Report Number
- 134213
- Event Type
- Injury
- Date Received
- November 19, 1997
- Date of Event
- November 12, 1997
- Report Date
- November 17, 1997
- Manufacturer
- AESCULAP INSTRUMENT CORP.
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
BROKEN LAPAROSCOPIC GRASPING INSTRUMENT WITHIN THE PERITONEAL CAVITY THAT WAS UNABLE TO BE RETRIEVED LAPAROSCOPICALLY, AND REQUIRED CONVERSION TO OPEN PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATRAUMATIC GRASPERS | GRASPERS | GCJ | AESCULAP INSTRUMENT CORP. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Required Intervention |