FDA Adverse Event
Injury
Summary report: N
EEA XL 25MM STAPLER WITH 3.5MM STAPLES
MDR report key: 1153273
·
Received September 8, 2008
Report
- Report Number
- 1219930-2008-00669
- Event Type
- Injury
- Date Received
- September 8, 2008
- Date of Event
- August 13, 2008
- Report Date
- August 20, 2008
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- GDW
- PMA / PMN Number
- K062850
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT SENT: 09/08/2008.
Description of Event or Problem · 1
PROCEDURE TYPE: LAP TOTAL GASTRECTOMY. ACCORDING TO THE REPORTER: AFTER FIRING, THE CAMERA HAD BEEN REMOVED, SO THE DEVICE WAS TAKEN OUT OF THE PT BLINDLY, AND THEN IT WAS NOTICED THAT THE ANASTOMOSIS WAS TORN. THE PROCEDURE WAS CONVERTED TO OPEN TO CORRECT THE ANASTOMOSIS. NO BLEEDING WAS REPORTED AND NO FURTHER INCIDENT DETAILS WERE DISCLOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EEA XL 25MM STAPLER WITH 3.5MM STAPLES | DISPOSABLE SURGICAL STAPLER | GDW | NORTH HAVEN - USS | U8E115H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | 25MM DEVICE. LOT# U8A71| PRODUCT ID: EEAORVIL25| EXP DATE: 01/31/2011 |