FDA Adverse Event
Malfunction
Summary report: N
ENDO CATCH II 15MM SPECIMEN POUCH
MDR report key: 1019139
·
Received March 24, 2008
Report
- Report Number
- 9612501-2008-00017
- Event Type
- Malfunction
- Date Received
- March 24, 2008
- Report Date
- February 25, 2008
- Manufacturer
- SANTO DOMINGO - USS
- Product Code
- GCJ
- PMA / PMN Number
- K922123
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT SUBMITTED: MARCH 21, 2008.
Description of Event or Problem · 1
PROCEDURE: UNK. ACCORDING TO THE REPORTER: THE ENDOCATCH II BAG TORE DURING THE UNFOLDING. THERE WAS NO FURTHER REPORT OF PATIENT INJURY. THE SPECIMEN WAS MANUALLY REMOVED FROM THE PATIENT CAVITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO CATCH II 15MM SPECIMEN POUCH | SURGICAL HAND INSTRUMENT | GCJ | SANTO DOMINGO - USS | J6H02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |