FDA Adverse Event
Injury
Summary report: N
EEA XL 25MM STAPLER WITH 3.5MM STAPLES
MDR report key: 1233948
·
Received November 14, 2008
Report
- Report Number
- 1219930-2008-00827
- Event Type
- Injury
- Date Received
- November 14, 2008
- Date of Event
- October 11, 2008
- Report Date
- October 23, 2008
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- GDW
- PMA / PMN Number
- K062580
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT SENT TO FDA ON 11/14/08.
Description of Event or Problem · 1
PROCEDURE TYPE: ROUX-EN-Y. ACCORDING TO THE REPORTER: NO ABNORMALITIES WERE NOTED INTRA-OPERATIVELY AND PERI-STRIP STAPLE-LINE REINFORCEMENT MATERIAL WAS USED. TEN DAYS POST-OPERATIVELY THERE WAS A TOTAL DEHISCENCE OF THE GASTROJEJUNAL ANASTOMOSIS. THE PT WAS RE-OPERATED AND A NEW ROUX-EN-Y WAS DONE AFTER RESECTING A SMALL AMOUNT OF THE JEJUNAL TISSUE. THE PT IS REPORTED TO BE RECOVERING WELL.
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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |