FDA Adverse Event
Injury
Summary report: N
MULTIFIRE ENDO GIA 30-3.5 12MM STAPLER
MDR report key: 3010981
·
Received March 11, 2013
Report
- Report Number
- 2647580-2013-00127
- Event Type
- Injury
- Date Received
- March 11, 2013
- Report Date
- February 15, 2013
- Manufacturer
- COVIDIEN, FORMERLY USSC
- Product Code
- GDW
- PMA / PMN Number
- K900129
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: NEPHRECTOMY. ACCORDING TO THE REPORTER: WHEN THE SURGEON WAS ATTEMPTING TO USE THE MULTIFIRE EGIA INSTRUMENT TO TRANSECT THE RENAL VEIN, THE CARTRIDGE DID NOT FIRE PERFECTLY. THE PROBLEM WAS THAT DISTAL PART OF THE STAPLE DID NOT MAKE A B FORMATION. THE STAPLES JUST POKED THE DISTAL PART OF THE VEIN. AS A RESULT, THE VEIN WAS TORN. THE DAMAGE WAS CORRECTED BY USING ANOTHER CARTRIDGE (30-2.5MM). THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. NO REINFORCEMENT MATERIAL WAS USED. THE SURGERY WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE CONVERSION TO OPEN SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 102470 | MULTIFIRE ENDO GIA 30-3.5 12MM STAPLER | DISPOSABLE SURGICAL STAPLER | GDW | COVIDIEN, FORMERLY USSC | P0M0698 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |