FDA Adverse Event
Injury
Summary report: N
ENDO GIA ROTICULATOR 60-3.5 SULU
MDR report key: 1822821
·
Received August 30, 2010
Report
- Report Number
- 1219930-2010-00681
- Event Type
- Injury
- Date Received
- August 30, 2010
- Date of Event
- August 23, 2010
- Report Date
- August 23, 2010
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: THE SURGEON DID NOT NOTICE THERE WAS AN ISSUE UNTIL THE EEA APPLICATION AND NOTED THAT THE ORIGINAL STAPLE LINE HAD MISFIRED EARLIER IN THE CASE. THE STAPLES WERE PROPERLY FORMED ON THE ENDS OF THE STAPLE LINE, BUT THERE WERE UNFORMED IN THE CENTER. TWO OTHER STAPLE LOADS WERE FIRED WITH ANOTHER DEVICE. SURGERY TIME EXTENSION WAS REPORTED AS 25-30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA ROTICULATOR 60-3.5 SULU | DISPOSABLE STAPLER | GDW | UNITED STATES SURGICAL | N0F0429 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Other | MANUFACTURE DATE: 05/01/2010| LOT NUMBER: N0E0084UJ| EXPIRATION DATE: 05/31/2015| EGIAUSTND, EGIA ULTRA UNIVERSAL STAPLER |