FDA Adverse Event
Injury
Summary report: N
EGIA ULTRA UNIVERSAL STAPLER
MDR report key: 3818073
·
Received May 12, 2014
Report
- Report Number
- 1219930-2014-00360
- Event Type
- Injury
- Date Received
- May 12, 2014
- Date of Event
- February 13, 2014
- Report Date
- May 6, 2014
- Manufacturer
- COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
- Product Code
- GDW
- PMA / PMN Number
- K083519
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: RESECTION. ACCORDING TO THE REPORTER: TISSUE WAS TRANSECTED BUT STAPLES DID NOT DEPLOY FROM THE RELOAD. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE AND ADDITIONAL TISSUE WAS RESECTED. NO BUTTRESS MATERIAL WAS USED. SAMPLES ARE NOT AVAILABLE SINCE THEY WERE DISCARDED AFTER USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283287 | EGIA ULTRA UNIVERSAL STAPLER | DISPOSABLE SURGICAL STAPLER | GDW | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES | N2K0174UMX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Disability | MFG DATE: 04/01/2013| (B)(4): LOT #: N3D0166LX, EXP DATE: 04/30/2018, |