FDA Adverse Event
Injury
Summary report: N
EEA 31MM SINGLE USE STAPLER
MDR report key: 1052812
·
Received May 27, 2008
Report
- Report Number
- 1219930-2008-00404
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- April 21, 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
- JA
- 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 WITH END-TO-END ANASTOMOSIS. ACCORDING TO THE REPORTER: ON THE THIRD DAY POST-OPERATIVELY, A LEAK WAS OBSERVED. IT IS REPORTED THAT THE LEAK WAS BOWEL MATERIAL AND AN INFLAMMATION WAS ALSO NOTED. NO RE-OPERATION HAS BEEN PERFORMED. NO ABNORMALITIES WERE NOTED DURING FIRING OF THE DEVICE PROCEDURE OPERATIVELY. NO STAPLE REINFORCEMENT MATERIAL WAS USED, THE DONUTS WERE NORMAL, AND THE ANASTOMOSIS WAS LEAK TESTED WITH AIR AND WATER AND NOTHING ABNORMAL WAS NOTED. THE PT IS CURRENTLY UNDER OBSERVATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EEA 31MM SINGLE USE STAPLER | DISPOSABLE SURGICAL STAPLER | GDW | NORTH HAVEN - USS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R |