FDA Adverse Event
Other
Summary report: N
STRYKER 3MM GRASPER
MDR report key: 842970
·
Received April 23, 2007
Report
- Report Number
- MW1042696
- Event Type
- Other
- Date Received
- April 23, 2007
- Date of Event
- April 4, 2007
- Report Date
- April 23, 2007
- Manufacturer
- STRYKER ENDOSCOPY
- Product Code
- HTD
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- KY, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
GRASPER GRASPING END BROKE OFF DURING REMOVAL OF APPENDIX THROUGH A TROCAR. RIVOT HAD SEPARATED FROM THE ONE GRASPER HINGE POINT. MAY HAVE BEEN DUE TO PRESSURE APPLIED. NO DIRECT PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRYKER 3MM GRASPER | STRYKER GRASPER | HTD | STRYKER ENDOSCOPY | * | 0440791 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | Other |