FDA Adverse Event
Malfunction
Summary report: N
ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL
MDR report key: 2243255
·
Received September 1, 2011
Report
- Report Number
- 9612501-2011-00044
- Event Type
- Malfunction
- Date Received
- September 1, 2011
- Date of Event
- June 16, 2011
- Report Date
- August 16, 2011
- Manufacturer
- DAVIS AND GECK CARIBE, LTD.
- Product Code
- GCI
- 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
PROCEDURE TYPE: LAP CHOLE. ACCORDING TO THE REPORTER: AFTER HAVING REMOVED THE GALL BLADDER, THE BAG BROKE IN THE PATIENT'S CAVITY. A METALLIC PIECE OF IT FELL OFF BUT WAS RETRIEVED BY THE SURGEON. NO CONSEQUENCES WERE REPORTED FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL | SINGLE USE LAPAROSCOPIC HAND INSTRUMENT | GCI | DAVIS AND GECK CARIBE, LTD. | J1A0019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |