FDA Adverse Event
Injury
Summary report: N
ENSEAL TRIO 3MM CURVED JAW
MDR report key: 2133537
·
Received June 14, 2011
Report
- Report Number
- MW5021020
- Event Type
- Injury
- Date Received
- June 14, 2011
- Date of Event
- June 6, 2011
- Report Date
- June 14, 2011
- Manufacturer
- ETHICON ENDO-SURGERY
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- SC, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PORTION OF CURVED JAW BROKE OFF INTO PT'S ABDOMEN DURING LAPAROSCOPIC SURGERY. BROKEN PORTION OF INSTRUMENT RETRIEVED BY SURGEON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENSEAL TRIO 3MM CURVED JAW | CURVED JAW | GEI | ETHICON ENDO-SURGERY | H43U1N |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Disability |