FDA Adverse Event
Malfunction
Summary report: N
PROXIMATE RELOADABLE LINEAR STAPLER - 60 MM
MDR report key: 1831423
·
Received December 17, 2007
Report
- Report Number
- 1527736-2007-08516
- Event Type
- Malfunction
- Date Received
- December 17, 2007
- Date of Event
- November 23, 2007
- Report Date
- November 29, 2007
- Manufacturer
- ETHICON ENDO SURGERY, INC. (CINCINNATI)
- Product Code
- GDW
- PMA / PMN Number
- K020779
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN OPEN COLON RESECTION PROCEDURE, THE STAPLE LINE DID NOT HOLD AFTER FIRING. THE STAPLES WERE MALFORMED. USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE RELOADABLE LINEAR STAPLER - 60 MM | GDW | ETHICON ENDO SURGERY, INC. (CINCINNATI) | NA | D4JD8A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |