FDA Adverse Event
Malfunction
Summary report: N
ENDOPOUCH RETRIEVER SPEC BAG
MDR report key: 1821149
·
Received August 10, 2007
Report
- Report Number
- 1527736-2007-05300
- Event Type
- Malfunction
- Date Received
- August 10, 2007
- Date of Event
- August 6, 2007
- Report Date
- August 7, 2007
- Manufacturer
- ETHICON ENDO SURGERY, INC (CINCINNATI)
- Product Code
- GCJ
- PMA / PMN Number
- K011501
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE POUCH WAS TORN PRIOR TO USE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPOUCH RETRIEVER SPEC BAG | GCJ | ETHICON ENDO SURGERY, INC (CINCINNATI) | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |