FDA Adverse Event
Malfunction
Summary report: N
BOWEL GRASPER
MDR report key: 5515867
·
Received March 17, 2016
Report
- Report Number
- MW5061015
- Event Type
- Malfunction
- Date Received
- March 17, 2016
- Date of Event
- March 1, 2016
- Report Date
- March 17, 2016
- Manufacturer
- STORZ
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
DURING SCHEDULED LAP APPENDECTOMY, SURGEON NOTICED ONE SIDE OF 3 CM JAW OF BOWEL GRASPER WAS MISSING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 163308 | BOWEL GRASPER | BOWEL GRASPER | GCJ | STORZ | 33132 | GC03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR |