FDA Adverse Event
Malfunction
Summary report: N
ENDO CATCH II 15MM SPECIMEN POUCH
MDR report key: 1010120
·
Received March 10, 2008
Report
- Report Number
- 9612501-2008-00015
- Event Type
- Malfunction
- Date Received
- March 10, 2008
- Date of Event
- November 27, 2007
- Report Date
- February 18, 2008
- Manufacturer
- SANTO DOMINGO - USS
- Product Code
- GCJ
- PMA / PMN Number
- K922123
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT SUBMITTED; MARCH 10, 2008.
Description of Event or Problem · 1
PROCEDURE: LAP CHOLE. ACCORDING TO THE REPORTER: A PIECE OF METAL CAME OFF THE DEVICE DURING REMOVAL OF THE GALLBLADDER. THE PIECE WAS REMOVED FROM THE PT. THERE WAS NO REPORT OF PT INJURY OR IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO CATCH II 15MM SPECIMEN POUCH | SPECIMEN POUCH | GCJ | SANTO DOMINGO - USS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |