FDA Adverse Event
Injury
Summary report: N
DST SERIES EEA ORVIL 25MM DEVICE
MDR report key: 2221551
·
Received August 18, 2011
Report
- Report Number
- 2647580-2011-00552
- Event Type
- Injury
- Date Received
- August 18, 2011
- Date of Event
- July 29, 2011
- Report Date
- August 1, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K062850
- 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 GASTRIC BYPASS. ACCORDING TO THE REPORTER: THE ANVIL AND THE DEVICE COULD NOT BE CONNECTED. ADDITIONAL RESECTION UNDER 3CM WAS DONE AND ANOTHER DEVICE WAS USED FOR ANASTOMOSIS. BLEEDING UNDER 200CC OCCURRED. OPERATIVE TIME WAS EXTENDED MORE THAN 30MINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DST SERIES EEA ORVIL 25MM DEVICE | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | UNITED STATES SURGICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | EEA XL 25MM SINGLE-USE STAPLER: CAT #EEAXL25| K062850| LOT: P0M1429H, EXP: 12/31/2015, MANUF: 12/2010, |