FDA Adverse Event
Injury
Summary report: N
PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT
MDR report key: 1564181
·
Received December 21, 2009
Report
- Report Number
- 3005075853-2009-07826
- Event Type
- Injury
- Date Received
- December 21, 2009
- Date of Event
- September 25, 2009
- Report Date
- November 27, 2009
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K020779
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER AN UNKNOWN PROCEDURE, THE STAPLES WOULD NOT HOLD. THE ANASTOMOSIS WAS FOUND OPEN ACROSS THE WHOLE LINE OF STAPLES. THERE WAS A REOPERATION. THE EVENT OUTCOME WAS PERITONITIS, COLONIC ABLATION AND STOMA. REQUESTED THE FOLLOWING INFORMATION ON 12/21/2009.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT | GDW STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. | NA | F4P569 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | CARTRIDGE |