FDA Adverse Event
Injury
Summary report: N
EEA XL 21MM SINGLE-USE STAPLER
MDR report key: 1201570
·
Received October 17, 2008
Report
- Report Number
- 1219930-2008-00747
- Event Type
- Injury
- Date Received
- October 17, 2008
- Date of Event
- September 10, 2008
- Report Date
- September 24, 2008
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- GDW
- PMA / PMN Number
- K062850
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT SENT: 10/16/2008.
Description of Event or Problem · 1
PROCEDURE TYPE: ROUX-EN-Y. ACCORDING TO THE REPORTER: THE ANVIL WOULD NOT TILT AND WAS HARD TO REMOVE THE DEVICE FROM THE ANASTOMOSIS. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. SURGERY TIME WAS EXTENDED TEN MINUTES AS A RESULT. NO TISSUE DAMAGE AND NO BLOOD LOSS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EEA XL 21MM SINGLE-USE STAPLER | DISPOSABLE SURGICAL STAPLER | GDW | NORTH HAVEN - USS | U8D41H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | PRODUCT ID: EEAORVIL25| DST SERIES EEA ORVIL 25MM DEVICE |