FDA Adverse Event
Injury
Summary report: N
PREMIUM PLUS CEEA 31 INSTR. W/TILT-TOP
MDR report key: 2831016
·
Received November 1, 2012
Report
- Report Number
- 2647580-2012-00690
- Event Type
- Injury
- Date Received
- November 1, 2012
- Report Date
- October 9, 2012
- Manufacturer
- COVIDIEN, FORMERLY USSC PUERTO RICO
- Product Code
- GDW
- PMA / PMN Number
- K001895
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: AFTER FIRING, THE DEVICE COULD NOT BE REMOVED. THE DEVICE DID NOT TILT, AND STUCK INSIDE OF THE BODY. TISSUE WAS DAMAGED BY THIS PRODUCT AND HE HAD TO SUTURE AROUND STAPLE LINE FOR HEMOSTASIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PREMIUM PLUS CEEA 31 INSTR. W/TILT-TOP | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | COVIDIEN, FORMERLY USSC PUERTO RICO | P1K1027X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |