FDA Adverse Event
Malfunction
Summary report: N
ENDO GIA* II 45-3.5 DLU
MDR report key: 3964113
·
Received May 22, 2014
Report
- Report Number
- 1219930-2014-00391
- Event Type
- Malfunction
- Date Received
- May 22, 2014
- Report Date
- May 16, 2014
- Manufacturer
- COVIDIEN, FORMERLY US SUR
- Product Code
- GDW
- PMA / PMN Number
- K900129
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: THERE WAS POSTOPERATIVE BLEEDING. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO TISSUE DAMAGE. THERE WAS NO BLOOD LOSS. NO TRANSFUSION WAS NEEDED. NO REINFORCEMENT MATERIAL USED. RE-OPERATION WAS NEEDED AND THERE WAS EXTENDED HOSPITAL STAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 306656 | ENDO GIA* II 45-3.5 DLU | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | COVIDIEN, FORMERLY US SUR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |