FDA Adverse Event
Malfunction
Summary report: N
TA
MDR report key: 1003951
·
Received February 1, 2008
Report
- Report Number
- 1003951
- Event Type
- Malfunction
- Date Received
- February 1, 2008
- Date of Event
- December 10, 2007
- Report Date
- January 31, 2008
- Manufacturer
- COVIDIEN UNITED STATES SURGICAL CORPORATION
- Product Code
- GAG
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
FAILURE OF TA30 STAPLER IN THE PELVIS. THE RESIDENT SURGEON WAS USING A TA3035 STAPLER TO TRANSECTED THE LOWER BOWEL. LATER ON THE SURGEON ASKED IF THE TA30 STAPLER HAD FIRED TO TRANSECT THE LOWER BOWEL AND THEN SHE LOOKED IN THE SURGICAL SITE. WE TESTED THE TA STAPLER ON A TOWEL AND IT FIRED AND STAPLED FOR HER. SO AT THAT TIME WE FIRST USED THE STAPLER AND WE HAD NOT NOTICED THAT IT HAD NOT FIRED FOR THE RESIDENT. THEN SURGEON STATED SHE WAS GOING TO HAVE TO HAND SEW THE BOWEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TA | STAPLER, SURGICAL | GAG | COVIDIEN UNITED STATES SURGICAL CORPORATION | * | P7H0179 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |