FDA Adverse Event
Injury
Summary report: N
EEA XL 28MM SINGLE-USE STAPLER
MDR report key: 1131993
·
Received August 21, 2008
Report
- Report Number
- 1219930-2008-00624
- Event Type
- Injury
- Date Received
- August 21, 2008
- Date of Event
- July 25, 2008
- Report Date
- August 1, 2008
- Manufacturer
- NORTH HAVEN-USS
- Product Code
- GDW
- PMA / PMN Number
- K062850
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT SENT: 08/20/2008.
Description of Event or Problem · 1
PROCEDURE TYPE: SIGMOID RESECTION. ACCORDING TO THE REPORTER: HALF OF THE STAPLE LINE FORMED. A HOLE AT THE RECTUM SIDE WAS SEEN. THE DOCTOR THEN HAND SEW THE AREA TO SECURE THE ANASTOMOSIS. SURGERY TIME WAS EXTENDED THIRTY MINS AS A RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EEA XL 28MM SINGLE-USE STAPLER | DISPOSABLE SURGICAL STAPLER | GDW | NORTH HAVEN-USS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |