FDA Adverse Event
Malfunction
Summary report: N
TA30-V3S STAPLER
MDR report key: 4161579
·
Received July 23, 2014
Report
- Report Number
- 2647580-2014-00561
- Event Type
- Malfunction
- Date Received
- July 23, 2014
- Date of Event
- August 23, 2013
- Report Date
- August 28, 2013
- Manufacturer
- COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
- Product Code
- GDW
- PMA / PMN Number
- K013860
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: THE DOCTOR WAS UNABLE TO FIRE THE DEVICE DURING THE CASE. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO BLEEDING IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 431024 | TA30-V3S STAPLER | DISPOSABLE SURGICAL STAPLER | GDW | COVIDIEN, FORMERLY USSC PUERTO RICO, INC. | P2J0539X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |