FDA Adverse Event
Injury
Summary report: N
MULTIFIRE ENDO GIA 30-3.5 12MM STAPLER
MDR report key: 2142835
·
Received June 21, 2011
Report
- Report Number
- 2647580-2011-00403
- Event Type
- Injury
- Date Received
- June 21, 2011
- Date of Event
- June 9, 2011
- Report Date
- June 9, 2011
- Manufacturer
- USSC PUERTO RICO
- Product Code
- GDW
- PMA / PMN Number
- K900129
- 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 TYPE: LAP APPENDECTOMY. ACCORDING TO THE REPORTER: THE RELOAD WAS IMPROPERLY UNLOADED, LEADING THE RELOAD TO BE INCORRECTLY LOADED AND FIRED. THE RELOAD BROKE APART INSIDE PT POST-FIRING. ALL PARTS WERE RECOVERED AND CONFIRMED THROUGH X-RAY. THE CASE WAS DELAYED MORE THAN 30 MINUTES. NO BLEEDING REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTIFIRE ENDO GIA 30-3.5 12MM STAPLER | DISPOSABLE SURGICAL STAPLER | GDW | USSC PUERTO RICO | P0M0697 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Other | MULTIFIRE ENDO GIA 30-3.5 SULU: CAT# 030807L |