FDA Adverse Event
Injury
Summary report: N
DST SERIES EEA ORVIL 25MM DEVICE
MDR report key: 3787046
·
Received April 25, 2014
Report
- Report Number
- 1219930-2014-00329
- Event Type
- Injury
- Date Received
- April 25, 2014
- Date of Event
- April 1, 2014
- Report Date
- April 3, 2014
- Manufacturer
- COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
- Product Code
- GAG
- PMA / PMN Number
- K093402
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: LAPAROSCOPIC TOTAL GASTRECTOMY. ACCORDING TO THE REPORTER: THERE WAS NO PROBLEM WITH THE INSERTION OF THE ANVIL. HOWEVER, THERE WAS DIFFICULTY IN ATTACHING THE ANVIL TO THE EEA STAPLER. THE ANVIL HAD TO BE INSERTED THROUGH THE SURGICAL OPENING IN THE ABDOMEN. THERE WAS ADD'L TISSUE THAT WAS RESECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 250467 | DST SERIES EEA ORVIL 25MM DEVICE | DISPOSABLE SURGICAL STAPLING DEVICE | GAG | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | EEAXL25, EEA XL 25MM SINGLE-USE STAPLER |