FDA Adverse Event
Injury
Summary report: N
GIA UNIVERSAL
MDR report key: 1890017
·
Received November 1, 2010
Report
- Report Number
- 1219930-2010-00820
- Event Type
- Injury
- Date Received
- November 1, 2010
- Date of Event
- October 1, 2010
- Report Date
- October 8, 2010
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: LOBECTOMY: ACCORDING TO THE REPORTER: STAPLER FIRED ACROSS PULMONARY VEIN AND WOULD NOT OPEN. BLACK KNOBS RETRACTED BUT KNIFE BLADE ASSEMBLY DID NOT RETRACT. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. TA30 WAS PLACED ON PROXIMAL SIDE OF STAPLER AND FIRED STAPLER THEN RESECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GIA UNIVERSAL | DISPOSABLE STAPLER | GDW | UNITED STATES SURGICAL | N0H0292 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability | ENDO GIA ROTICULATOR 60-2.5 SULU, (B)(4)| MANUFACTURE DATE: 09/2015| LOT NUMBER: N0J0058| EXPIRATION DATE: 09/30/2015 |