FDA Adverse Event
Injury
Summary report: N
EEA 28MM SINGLE-USE STAPLER
MDR report key: 1052813
·
Received May 27, 2008
Report
- Report Number
- 1219930-2008-00405
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- April 30, 2008
- Report Date
- April 30, 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
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT SENT: 05/23/2008
Description of Event or Problem · 1
PROCEDURE TYPE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: THE DEVICE WAS FIRED ON VERY LOW RECTAL CANCER. AFTER APPLYING THE DEVICE, A FISTULA WAS FOUND ON THE ANASTOMOSIS. THE SURGEON REINFORCED THE ANASTOMOSIS WITH SUTURE TO AVOID A COLOSTOMY. A DRAIN WAS ALSO PLACED IN PT. SURGERY TIME WAS EXTENDED ONE HR, AND NO BLEEDING OCCURRED AS A RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EEA 28MM SINGLE-USE STAPLER | DISPOSABLE SURGICAL STAPLER | GDW | NORTH HAVEN - USS | U7F09 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |