FDA Adverse Event
Malfunction
Summary report: N
ENDO CATCH II
MDR report key: 3052106
·
Received March 29, 2013
Report
- Report Number
- 3052106
- Event Type
- Malfunction
- Date Received
- March 29, 2013
- Date of Event
- March 26, 2013
- Report Date
- March 29, 2013
- Manufacturer
- COVIDIEN
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL, US
Narratives
Description of Event or Problem · 1
UPON OPENING BY THE DOCTOR, THE DEVICE BAG RIPPED. THE DEVICE WAS REMOVED.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 129642 | ENDO CATCH II | SPECIMEN RETRIEVAL | GCJ | COVIDIEN | * | J1B0020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |