FDA Adverse Event
Injury
Summary report: N
EEA 31MM SINGLE-USE STAPLER
MDR report key: 1145283
·
Received September 2, 2008
Report
- Report Number
- 1219930-2008-00654
- Event Type
- Injury
- Date Received
- September 2, 2008
- Date of Event
- August 14, 2008
- Report Date
- August 18, 2008
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- GDW
- PMA / PMN Number
- K062850
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT SENT: 09/02/2008.
Description of Event or Problem · 1
PROCEDURE TYPE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: THE SURGEON CLAMPED DOWN THE DEVICE AND UPON FIRING, IT TORE TISSUE THROUGH THE CEROSA MUSCLE. THIS OCCURRED AT THE DISTAL END ON THE RECTUM SIDE OF THE COLON. THE ANASTOMOSIS, STAPLE LINE AND DONUTS, WAS COMPLETE BUT THE SURGEON APPLIED APPROXIMATELY SIX SUTURES TO REPAIR THE TEAR. NO LEAKS AND NO ABNORMAL BLEEDING WERE NOTED BUT SURGERY TIME WAS EXTENDED BY THIRTY MINUTES AS A RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EEA 31MM SINGLE-USE STAPLER | DISPOSABLE SURGICAL STAPLER | GDW | NORTH HAVEN - USS | U6M33 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |