FDA Adverse Event
Malfunction
Summary report: N
ENDOPOUCH RETRIEVER SPEC BAG
MDR report key: 1182574
·
Received October 3, 2008
Report
- Report Number
- 1527736-2008-03672
- Event Type
- Malfunction
- Date Received
- October 3, 2008
- Date of Event
- May 20, 2008
- Report Date
- May 23, 2008
- 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
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 06/11/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY, THE SURGEON PRESSED DOWN ON THE PLUNGER AND THE BAG DEPLOYED, BUT HE WAS UNABLE TO LIFT BACK UP ON THE PLUNGER. THE SURGEON HAD TO REMOVE THE SPECIMEN THROUGH THE PORT SITE. THERE WAS NO PT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPOUCH RETRIEVER SPEC BAG | NONE | GCJ | ETHICON ENDO SURGERY, INC. (CINCINNATI) | NA | E4KH4M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |