FDA Adverse Event
Injury
Summary report: N
ENDO GIA ROTICULATOR 60-3.5 SULU
MDR report key: 1905777
·
Received November 17, 2010
Report
- Report Number
- 1219930-2010-00880
- Event Type
- Injury
- Date Received
- November 17, 2010
- Date of Event
- November 12, 2010
- Report Date
- November 15, 2010
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: LOBECTOMY. ACCORDING TO THE REPORTER: AFTER FIRING, THE JAWS WOULD NOT OPEN. THE INSTRUMENT WAS RESECTED WITH THE USE OF ANOTHER DEVICE.
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 | N0G0659 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability | GIA UNIVERSAL, (B)(4) |