FDA Adverse Event
Malfunction
Summary report: N
ETS FLEX ARTICNG LNR CUTR 45MM
MDR report key: 1315999
·
Received February 20, 2009
Report
- Report Number
- 3005075853-2008-03078
- Event Type
- Malfunction
- Date Received
- February 20, 2009
- Date of Event
- October 31, 2008
- Report Date
- November 11, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K020779
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAP APPENDECTOMY PROCEDURE. THE CASE WAS CONVERTED TO OPEN PRIOR TO USING OUR DEVICE. THE SCRUB TECH HANDED OFF THE DEVICE WITH AFTER LOADING IT, AND IT WAS FIRED. THE DEVICE CUT BUT DID NOT STAPLE. SINCE THE PROCEDURE HAD BEEN CONVERTED TO OPEN, THEY WERE ABLE TO OVERSEW THE STAPLE LINE WITHOUT ANY ADVERSE CONSEQUENCE TO THE PT. THE DEVICE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETS FLEX ARTICNG LNR CUTR 45MM | GDW | GDW | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |