FDA Adverse Event
Injury
Summary report: N
EEA 31MM SINGLE-USE STAPLER
MDR report key: 3981354
·
Received July 24, 2014
Report
- Report Number
- 2647580-2014-00571
- Event Type
- Injury
- Date Received
- July 24, 2014
- Date of Event
- June 26, 2014
- Report Date
- July 10, 2014
- Manufacturer
- COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
- Product Code
- GDW
- PMA / PMN Number
- K062850
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: COLORECTAL. ACCORDING TO THE REPORTER: DURING THE PROCEDURE, THE SAFETY LEVER OF THE STAPLER COULD NOT BE MOVED, BLOCKING THE LEVER FROM BEING ABLE TO SQUEEZE AND FIRE. THE DEVICE WAS REMOVED AND THE DOCTOR APPLIED A NEW DEVICE TO COMPLETE THE PROCEDURE. THERE WAS UNANTICIPATED TISSUE LOSS. THERE WAS UNANTICIPATED TISSUE DAMAGE. THERE WAS NO UNANTICIPATED BLOOD LOSS OF MORE THAN 500CC. THERE WAS AN EXTENSION OF OPERATING TIME BY MORE THAN 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 435384 | EEA 31MM SINGLE-USE STAPLER | DISPOSABLE SURGICAL STAPLER | GDW | COVIDIEN, FORMERLY USSC PUERTO RICO, INC. | P3C0065X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Other |