FDA Adverse Event
Injury
Summary report: N
EGIA 45 ARTICULATING VAS/MED SULU
MDR report key: 3902272
·
Received June 25, 2014
Report
- Report Number
- 1219930-2014-00476
- Event Type
- Injury
- Date Received
- June 25, 2014
- Date of Event
- June 23, 2014
- Report Date
- June 24, 2014
- Manufacturer
- COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
- Product Code
- GDW
- PMA / PMN Number
- K101444
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: LAP APPENDECTOMY. ACCORDING TO THE REPORTER: THREE ROWS OF STAPLES ON ONE SIDE OF THE STAPLER DID NOT APPEAR TO BE PRESENT. THE DEVICE WAS COMPLETELY CYCLED AND IT CUT. THE SIDE THAT DID NOT FIRE WAS THE PATIENT SIDE. THIS RESULTED IN AN OPEN CECUM WHICH WAS MANUALLY SUTURED. NO BUTTRESS MATERIAL USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 370578 | EGIA 45 ARTICULATING VAS/MED SULU | DISPOSABLE SURGICAL STAPLER | GDW | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES | N4D1626KX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EGIA ULTRA UNIVERSAL STAPLER, EGIAUSTND, K083519 |