FDA Adverse Event
Injury
Summary report: N
GIA UNIVERSAL
MDR report key: 1832028
·
Received September 8, 2010
Report
- Report Number
- 1219930-2010-00706
- Event Type
- Injury
- Date Received
- September 8, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 2, 2010
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
PROCEDURE: VATS. ACCORDING TO THE REPORTER: WITH THE FIRST FIRING WITH GIA UNIVERSAL HANDLE AND 60MM 4.8MM ROTIC; THE SURGEON NOTICED INCREASED FORCE NEEDED TO ARTICULATE THE LOAD. AS THE FIRST LOAD WAS FIRED, MORE TENSION WAS FELT WHILE SQUEEZING THE HANDLE. THE LOAD WAS FIRED COMPLETELY. AFTER PULLING THE BLACK KNOBS BACK AFTER FIRING, IT WAS APPARENT THAT ONLY THREE ROWS OF STAPLES WERE PLACED ON THE SPECIMEN SIDE OF THE KNIFE STAPLE. THE SURGEON PROCEEDED BY CLAMPING THE PATIENT SIDE OF THE LUNG TO MINIMIZE BLEEDING. BLOOD LOSS WAS REPORTED AS 600CC. THE CASE WAS DELAYED MORE THAN 30 MINUTES. THE CASE WAS COMPLETED WITH ANOTHER DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GIA UNIVERSAL | DISPOSABLE STAPLER | GDW | UNITED STATES SURGICAL | N0C0234 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention | 030459, ENDO GIA ROTICULATOR 60-4.8 SULU| LOT NUMBER: N0A0585, EXPIRATION DATE: 01/31/2015| MANUFACTURE DATE: 01/2010 |