FDA Adverse Event
Injury
Summary report: N
ENDO GIA UNIVERSAL 12MM SINGLE USE INST
MDR report key: 1832009
·
Received September 8, 2010
Report
- Report Number
- 1219930-2010-00705
- Event Type
- Injury
- Date Received
- September 8, 2010
- Date of Event
- August 2, 2010
- Report Date
- September 1, 2010
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
PROCEDURE: BULLECTOMY. ACCORDING TO THE REPORTER: AFTER FIRING, IT WAS NOT POSSIBLE TO OPEN THE JAWS. THE INSTRUMENT WAS RESECTED WITH THE USE OF ANOTHER DEVICE THROUGH ANOTHER PORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA UNIVERSAL 12MM SINGLE USE INST | DISPOSABLE STAPLER | GDW | UNITED STATES SURGICAL | N0B0049 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability | MANUFACTURE DATE: 12/2009| LOT NUMBER: N9M0567, EXPIRATION DATE: 12/31/2014| 030455, ENDO GIA ROTICULATOR 45-3.5 SULU |