FDA Adverse Event
Injury
Summary report: N
SNOWDEN-PENCER, INC.
MDR report key: 147805
·
Received January 9, 1998
Report
- Report Number
- 147805
- Event Type
- Injury
- Date Received
- January 9, 1998
- Date of Event
- August 13, 1997
- Report Date
- September 29, 1997
- Manufacturer
- SNOWDEN-PENCER
- Product Code
- GCJ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT UNDERGOING A LAPAROSCOPIC CHOLECYSTECTOMY, A SMALL PIECE OF LAPAROSCOPIC GRASPER BROKE IN THE PT. X-RAY PERFORMED AND THE GRASPER TIP WAS LOCATED AND REMOVED FROM THE PT. PT RECOVERED WELL WITH NO COMPLICATIONS. THE RETRIEVED TIP WAS ACCIDENTALLY DISCHARGED. THE INCIDENT ADDED APPROX ONE AND A HALF HRS TO THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SNOWDEN-PENCER, INC. | LAPAROSCOPIC GRASPER | GCJ | SNOWDEN-PENCER | 90-3005 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |