FDA Adverse Event
Injury
Summary report: N
ENDO GIA UNIVERSAL 12MM SINGLE USE INST
MDR report key: 1832027
·
Received September 8, 2010
Report
- Report Number
- 1219930-2010-00707
- Event Type
- Injury
- Date Received
- September 8, 2010
- Date of Event
- August 31, 2010
- Report Date
- September 8, 2010
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- 203-492
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
PROCEDURE: PNEUMONECTOMY. ACCORDING TO THE REPORTER: THE INSTRUMENT WAS HARD TO FIRE. THE STAPLING WAS DONE CROSSING THE FIRST STAPLED LINE. STAPLES DID NOT FORM PROPERLY AND ADDITIONAL TISSUE WAS RESECTED. BLEEDING WAS REPORTED AS UNDER 200CC.
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 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 030455, ENDO GIA ROTICULATOR 45-3.5 SULU |