FDA Adverse Event
Injury
Summary report: N
ETS FLEX ARTICNG LNR CUTR 45MM
MDR report key: 1140991
·
Received August 29, 2008
Report
- Report Number
- 3005075853-2008-01432
- Event Type
- Injury
- Date Received
- August 29, 2008
- Date of Event
- August 8, 2008
- Report Date
- August 8, 2008
- 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
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
D4; H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAP APPENDECTOMY PROCEDURE, THE DEVICE WAS FIRED ACROSS THE APPENDIX. THE SURGEON VISUALLY CHECKED THE STAPLE LINE AND IDENTIFIED THE DEVICE HAD CUT BUT NOT STAPLED, AND THE STAPLE LINE WAS OPEN. THE SURGEON CONVERTED TO AN OPEN PROCEDURE AS A RESULT OF THE OPEN STAPLE LINE. A PARTIAL REMOVAL OF THE CECUM WAS PERFORMED AND THEY CLOSED WITH SUTURE. THE PT WILL REMAIN IN THE HOSP FOR AND EXTENDED STAY TO RECOVER, DUE TO AN OPEN PROCEDURE BEING REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETS FLEX ARTICNG LNR CUTR 45MM | GDW | ETHICON ENDO-SURGERY, LLC. | NA | E4LA7N |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |