FDA Adverse Event
Injury
Summary report: N
EEA 25MM SINGLE-USE STAPLER
MDR report key: 1221921
·
Received November 4, 2008
Report
- Report Number
- 1219930-2008-00806
- Event Type
- Injury
- Date Received
- November 4, 2008
- Date of Event
- October 17, 2008
- Report Date
- October 17, 2008
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- GDW
- PMA / PMN Number
- K062850
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT SENT: 11/04/08.
Description of Event or Problem · 1
PROCEDURE TYPE: HEMICOLECTOMY. ACCORDING TO THE REPORTER: THE SURGEON WAS NOT ABLE TO CLOSE THE INSTRUMENT IN ORDER TO SEE THE GREEN INDICATOR. THIS WAS PROBABLY DUE TO EXCESS TISSUE BETWEEN THE ANVIL AND THE CARTRIDGE. FINALLY, THE SURGEON DECIDED TO OPEN THE INSTRUMENT AND HE SAW THE ANVIL WAS TILTED. THE INSTRUMENT WAS NOT APPLIED AND THE ANASTOMOSIS WAS MANUALLY DONE WITH SUTURE. NO BLOOD LOSS OR SURGERY DELAY WAS REPORTED. THE PT'S TISSUE WAS HARDER THAN NORMAL AS IT HAD BEEN RADIATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EEA 25MM SINGLE-USE STAPLER | DISPOSABLE SURGICAL STAPLER | GDW | NORTH HAVEN - USS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |