FDA Adverse Event
Injury
Summary report: N
ENDO GIA UNIVERSAL 12MM SINGLE USE INST
MDR report key: 3011026
·
Received March 11, 2013
Report
- Report Number
- 1219930-2013-00206
- Event Type
- Injury
- Date Received
- March 11, 2013
- Date of Event
- February 13, 2013
- Report Date
- February 13, 2013
- Manufacturer
- COVIDIEN, FORMERLY US SUR
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: GASTRECTOMY. ACCORDING TO THE REPORTER: FIRED DEVICE FINE BUT WHEN THEY PULLED THE DEVICE OUT OF THE PORT THEY NOTICED THE JAWS DID NOT MEET. THEY WERE CONCERNED THE STAPLES MAY NOT HAVE FIRED, SO THEY CONVERTED TO OPEN. TISSUE SEEMED NORMAL AND THE PATIENT IS FINE. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 102534 | ENDO GIA UNIVERSAL 12MM SINGLE USE INST | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | COVIDIEN, FORMERLY US SUR | N2C0447X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | LOT #UNK, K061095| ENDO GIA ROTICULATOR: 60-3.5 SULU, (B)(4) |