FDA Adverse Event
Injury
Summary report: N
EEA XL 25MM STAPLER WITH 3.5MM STAPLES
MDR report key: 1153279
·
Received September 8, 2008
Report
- Report Number
- 1219930-2008-00672
- Event Type
- Injury
- Date Received
- September 8, 2008
- Date of Event
- August 18, 2008
- Report Date
- August 21, 2008
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- GDW
- PMA / PMN Number
- K062850
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT SENT: 09/08/2008.
Description of Event or Problem · 1
PROCEDURE TYPE: GASTRIC BYPASS. ACCORDING TO THE REPORTER: ANVIL DID NOT TILT AFTER FIRING. THE ANVIL WAS MANUALLY REMOVED WITHOUT PATIENT HARM. SURGERY TIME WAS EXTENDED BY THIRTY MINUTES AS A RESULT.
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 | U8F94H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |