FDA Adverse Event
Injury
Summary report: N
EEA XL 25MM SINGLE-USE STAPLER
MDR report key: 3649376
·
Received February 21, 2014
Report
- Report Number
- 2647580-2014-00104
- Event Type
- Injury
- Date Received
- February 21, 2014
- Date of Event
- February 6, 2014
- Report Date
- February 6, 2014
- Manufacturer
- COVIDIEN, FORMERLY USSC
- Product Code
- GDW
- PMA / PMN Number
- K062850
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: GASTRECTOMY. ACCORDING TO THE REPORTER: SURGERY FOR A GASTRIC TUMOR. AFTER CONNECTION AND FIRING, THE STAPLES WERE NOT FORMED AND CUTTING WENT THROUGH. THE DIFFICULTY RESULTED IN IRREVERSIBLE TISSUE DAMAGE AS THE ANASTOMOSIS WAS REDONE. THERE WAS ANU UNANTICIPATED EXTENSION OF THE INCISION BY 20CM. SURGICAL LINE WAS DELAYED BY MORE THAN 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 109035 | EEA XL 25MM SINGLE-USE STAPLER | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | COVIDIEN, FORMERLY USSC | P3C0258X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Required Intervention | LOT NUMBER NOT AVAILABLE, COVIDIEN| DEVICE DST SERIES EEA ORVIL 25MM DEVICE:| EEAORVIL25 DISPOSABLE SURGICAL STAPLING |