FDA Adverse Event
Injury
Summary report: N
TA 60-3.5 SINGLE USE RELOADABLE STAPLER
MDR report key: 3940874
·
Received July 8, 2014
Report
- Report Number
- 2647580-2014-00509
- Event Type
- Injury
- Date Received
- July 8, 2014
- Date of Event
- May 2, 2014
- Report Date
- June 25, 2014
- Manufacturer
- COVIDIEN, FORMERLY USSC
- Product Code
- GDW
- PMA / PMN Number
- K013860
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: RIGHT HEMICOLECTOMY. ACCORDING TO THE REPORTER: THE DEVICE WAS FIRED BUT THE STAPLES DID NOT CLOSE. THIS REQUIRED RE-STAPLING OVER THE SAME STAPLE LINE WITH ANOTHER STAPLER. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO UNANTICIPATED TISSUE DAMAGE. THERE WAS NO UNANTICIPATED BLEEDING OF OVER 500CC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 395572 | TA 60-3.5 SINGLE USE RELOADABLE STAPLER | DISPOSABLE SURGICAL STAPLER | GDW | COVIDIEN, FORMERLY USSC | P4B0285KX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |