FDA Adverse Event
Injury
Summary report: N
CLICKLINE BOWEL GRASPER FORCEP INSERT LAPROSCOPIC BOWEL GRASPER
MDR report key: 18884946
·
Received March 8, 2024
Report
- Report Number
- MW5152600
- Event Type
- Injury
- Date Received
- March 8, 2024
- Date of Event
- March 1, 2024
- Report Date
- March 6, 2024
- Manufacturer
- KARL STORZ ENDOSCOPY AMERICA, INC.
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
TWO TINES OF LAPAROSCOPIC BOWEL GRASPER BROKE DURING LAPAROSCOPIC CHOLECYSTECTOMY. REQUIRED INTRAOPERATIVE LOCALIZATION FOR LAPAROSCOPIC REMOVAL. ALL PIECES SUCCESSFULLY REMOVED LAPAROSCOPICALLY. POST REMOVAL X-RAY DEMONSTRATED RESOLUTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 957099 | CLICKLINE BOWEL GRASPER FORCEP INSERT LAPROSCOPIC BOWEL GRASPER | LAPAROSCOPE, GENERAL & PLASTIC SURGERY | GCJ | KARL STORZ ENDOSCOPY AMERICA, INC. | ZW32 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Female | Required Intervention |