FDA Adverse Event
Malfunction
Summary report: N
ENDO CATCH GOLD
MDR report key: 4131329
·
Received September 15, 2014
Report
- Report Number
- 4131329
- Event Type
- Malfunction
- Date Received
- September 15, 2014
- Date of Event
- September 11, 2014
- Report Date
- September 15, 2014
- Manufacturer
- COVIDIEN LP
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- VA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
WHILE USING THE ENDOCATCH TO REMOVE THE GALLBLADDER, THE HANDLE OF THE CATCH BROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 569329 | ENDO CATCH GOLD | LAPAROSCOPE, GENERAL & PLASTIC SURGERY | GCJ | COVIDIEN LP | 173050G | J4F0013MX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |