FDA Adverse Event
Injury
Summary report: N
EGIA ULTRA UNIVERSAL STAPLER
MDR report key: 3082892
·
Received April 22, 2013
Report
- Report Number
- 1219930-2013-00311
- Event Type
- Injury
- Date Received
- April 22, 2013
- Date of Event
- February 19, 2013
- Report Date
- March 29, 2013
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K083519
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: TRANSPLANT. ACCORDING TO THE REPORTER: DURING STAPLING (CLOSING THE INSTRUMENT) THE KNIFE WENT THROUGH THE ARTERY, THEY DID NOT KNOW WHETHER OR NOT THE STAPLER HAD BEEN FIRED ALSO, UNFORTUNATELY, THEY HAVE THROWN AWAY THE STAPLER. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171431 | EGIA ULTRA UNIVERSAL STAPLER | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | COVIDIEN, FORMERLY US SURGICAL | N2K0657UMX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |