FDA Adverse Event
Malfunction
Summary report: N
ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL
MDR report key: 3131558
·
Received May 17, 2013
Report
- Report Number
- 9612501-2013-00047
- Event Type
- Malfunction
- Date Received
- May 17, 2013
- Date of Event
- April 16, 2013
- Report Date
- April 25, 2013
- Manufacturer
- COVIDIEN
- Product Code
- GCJ
- PMA / PMN Number
- K922123
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: WHILE TRYING TO PULL OUT THE VESICLE, THE BUCKLE FROM THE DEVICE BROKE INSIDE THE PATIENT'S CAVITY. WHILE TRYING TO RETRIEVE THE BROKEN PIECE, THE WALL OF THE ABDOMEN WAS A LITTLE BIT DAMAGED (SMALL EROSION). THE BROKEN PIECES WERE ALL RETRIEVED. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THERE WAS NO UNANTICIPATED TISSUE LOSS. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 220173 | ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL | SINGLE USE SPECIMEN RETRIEVAL | GCJ | COVIDIEN | J2H0220XM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR |