FDA Adverse Event
Malfunction
Summary report: N
PROXIMATE RELOADABLE LINEAR STAPLER
MDR report key: 1170363
·
Received September 12, 2008
Report
- Report Number
- 3005075853-2008-01672
- Event Type
- Malfunction
- Date Received
- September 12, 2008
- Date of Event
- August 11, 2008
- Report Date
- August 20, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K020779
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- 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 DURING A COLON RESECTION PROCEDURE, THE DEVICE WAS FIRED AND NO STAPLES RELEASED. THE SURGEON CLAIMS THE SAFETY WAS OFF AND THERE WERE NO STAPLES IN THE DEVICE WHEN IT WAS HANDED TO HIM. THE TISSUE WAS RESECTED AND SUTURES WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE RELOADABLE LINEAR STAPLER | GDW | ETHICON ENDO-SURGERY, LLC. | NA | E4LC90 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |