FDA Adverse Event
Malfunction
Summary report: N
TA
MDR report key: 13009675
·
Received December 15, 2021
Report
- Report Number
- 13009675
- Event Type
- Malfunction
- Date Received
- December 15, 2021
- Date of Event
- November 4, 2021
- Report Date
- December 2, 2021
- Manufacturer
- COVIDIEN LP
- Product Code
- GDW
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- UT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE STAPLER LOAD, OF THE COVIDIEN LP TA¿ STAPLER, DID NOT SNAP INTO THE STAPLER PROPERLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1906792 | TA | STAPLE, IMPLANTABLE | GDW | COVIDIEN LP | TA6035S | P1F1565 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25550 DA | Female |