FDA Adverse Event
Injury
Summary report: N
PREMIUM PLUS CEEA 28 INSTR W/TILT TOP
MDR report key: 1221920
·
Received November 4, 2008
Report
- Report Number
- 2647580-2008-00623
- Event Type
- Injury
- Date Received
- November 4, 2008
- Date of Event
- October 17, 2008
- Report Date
- October 17, 2008
- Manufacturer
- PONCE - USS
- Product Code
- GDW
- PMA / PMN Number
- K001895
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PROCEDURE TYPE: J-POUCH. ACCORDING TO THE REPORTER: THE STAPLER DID NOT CUT THE ANASTOMOSIS AFTER FIRING. INSTRUMENT WAS STUCK AND WAS REMOVED BY FORCE TEARING TISSUE. LEAKAGE RESULTED FROM THE FORCEFUL REMOVAL OF THE INSTRUMENT AND A STOMA WAS SET UP. SURGERY TIME WAS EXTENDED BY MORE THAN THIRTY MINUTES AS A RESULT. NO BLOOD LOSS WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PREMIUM PLUS CEEA 28 INSTR W/TILT TOP | DISPOSABLE SURGICAL STAPLER | GDW | PONCE - USS | P8E0222J |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Required Intervention| S |