FDA Adverse Event
Injury
Summary report: N
PREMIUM PLUS CEEA* 31 INSTR. W/TILT-TOP*
MDR report key: 4120917
·
Received September 26, 2014
Report
- Report Number
- 2647580-2014-00812
- Event Type
- Injury
- Date Received
- September 26, 2014
- Date of Event
- September 3, 2014
- Report Date
- September 12, 2014
- Manufacturer
- COVIDIEN, FORMERLY USSC PUERTO RICO INC
- Product Code
- GDW
- PMA / PMN Number
- K001895
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
PROCEDURE TYPE: ACCORDING TO THE REPORTER: THE DOCTOR FOUND IT DIFFICULT TO REMOVE THE DEVICE AFTER FIRING. EVENTUALLY, HE COULD MANAGE TO REMOVE IT AND CONFIRMED THE DONUTS WERE RETRIEVED. A POSTOPERATIVE LEAKAGE TEST SHOWED THAT NO PROBLEM HAD BEEN CONFIRMED. HOWEVER, TWO DAYS AFTER THE PROCEDURE, A FAILURE WITH THE SUTURING WAS DISCOVERED. NO COMPONENTS FELL INTO THE CAVITY. THERE WAS NO BLEEDING OF OVER 500CC. IT WAS ALSO REPORTED THAT THE POSTOPERATIVE LEAKAGE WAS CONFIRMED BY X-RAY IMAGING. THERE WAS NO NEED FOR REOPERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 601499 | PREMIUM PLUS CEEA* 31 INSTR. W/TILT-TOP* | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | COVIDIEN, FORMERLY USSC PUERTO RICO INC | 111989 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |