FDA Adverse Event
Malfunction
Summary report: N
VERSAPORT
MDR report key: 2992138
·
Received February 28, 2013
Report
- Report Number
- 2992138
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- February 27, 2013
- Report Date
- February 28, 2013
- Manufacturer
- COVIDIEN FORMERLY FORMERLY KENDALL A DIVISION OF TYCO HEALTHCARE
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- UT, US
Narratives
Description of Event or Problem · 1
DR PLACING A NUMBER 11 TROCAR INTO THE ABDOMEN, PART OF THE TIP BROKE INTO THE PATIENT'S FASCIA. DR CONVERTED THE SURGERY TO LAPAROTOMY BECAUSE THERE WAS SO MUCH SCAR TISSUE AND ADHESIONS THAT HE WAS UNABLE TO GET THE OVARY SAFELY. DR LOCATED BOTH OF THE PIECES OF THE TROCAR THAT WERE BROKEN FROM THE TROCAR. PICTURES AVAILABLE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPY TO REMOVE LEFT OVARY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 86877 | VERSAPORT | TROCAR | GCJ | COVIDIEN FORMERLY FORMERLY KENDALL A DIVISION OF TYCO HEALTHCARE | * | J2H0144X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR |