FDA Adverse Event
Injury
Summary report: N
COVIDIEN
MDR report key: 2452310
·
Received February 9, 2012
Report
- Report Number
- MW5024228
- Event Type
- Injury
- Date Received
- February 9, 2012
- Report Date
- February 9, 2012
- Manufacturer
- US SURGICAL - COVIDIEN
- Product Code
- GDW
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PHYSICIAN WAS PERFORMING A LAPAROSCOPIC APPENDECTOMY. THE COVIDIEN ENDO GIA ULTRA UNIVERSAL STAPLER WAS NOT FIRING ALL STAPLES. FIRING WAS RANDOM. REMOVED WITHOUT DIFFICULTY. WAS USED WITH ENDO GIA CURVED TIP RELOAD WITH TRI-STAPLE TECHNOLOGY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COVIDIEN | GIA STAPLER | GDW | US SURGICAL - COVIDIEN | EGIAUSTND | N1L0413UKX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Disability |