FDA Adverse Event
Malfunction
Summary report: N
ETHICON ENDO-SURGERY, INC
MDR report key: 2787992
·
Received October 5, 2012
Report
- Report Number
- MW5027218
- Event Type
- Malfunction
- Date Received
- October 5, 2012
- Date of Event
- May 29, 2012
- Report Date
- October 5, 2012
- Manufacturer
- ETHICON ENDO SURGERY
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DR. (B)(6) WAS INSERTING TROCARS FOR A LAP VENTRAL HERNIA WHEN THE TROCAR HE WAS INSERTING BROKE INTO PIECES AND SOME OF THE PIECES HAD TO BE RETRIEVED FROM ABDOMEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETHICON ENDO-SURGERY, INC | XCEL BLUNT TIP TROCAR | GCJ | ETHICON ENDO SURGERY | H12LP | 1725750 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR |