FDA Adverse Event
Other
Summary report: N
COVIDIEN
MDR report key: 3062768
·
Received April 11, 2013
Report
- Report Number
- MW5029759
- Event Type
- Other
- Date Received
- April 11, 2013
- Date of Event
- April 8, 2013
- Report Date
- April 11, 2013
- Manufacturer
- COVIDIEN
- Product Code
- GDW
- Report Source
- Voluntary report
- Reporter Location
- AK, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
COVIDIEN STAPLE TA90-3.5 WAS PLACED OVER TISSUE, FIRED, AND CUT. WHEN THE SURGEON (DR (B)(6)) RELEASED THE HANDLE, THE TISSUE WAS CUT, BUT THE PRODUCT DID NOT STAPLE (MISFIRED). ANOTHER STAPLER WAS OPENED AND USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 156159 | COVIDIEN | STAPLER TA 9035S | GDW | COVIDIEN | TA90355 | P2H0310X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |