FDA Adverse Event
Injury
Summary report: N
PREMIUM PLUS CEEA 25 INSTR. W/TILT-TOP
MDR report key: 2221283
·
Received August 17, 2011
Report
- Report Number
- 2647580-2011-00546
- Event Type
- Injury
- Date Received
- August 17, 2011
- Date of Event
- July 14, 2011
- Report Date
- August 5, 2011
- Manufacturer
- USSC PUERTO RICO
- Product Code
- GDW
- PMA / PMN Number
- K001895
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: JEJUNOSTOMIE. ACCORDING TO THE REPORTER: DURING THE SURGERY, AFTER THE ANVIL CONNECTION WITH THE STAPLER, THE DEVICE DID NOT FIRE. IT WAS NOT POSSIBLE TO REALIZE THE ANASTOMOSIS. NO INJURY WAS REPORTED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. OPERATIVE TIME WAS EXTENDED BY MORE THAN 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PREMIUM PLUS CEEA 25 INSTR. W/TILT-TOP | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | USSC PUERTO RICO | P0A0548J |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |