FDA Adverse Event
Malfunction
Summary report: N
ETS FLEX ARTICNG LNR CUTR 45MM
MDR report key: 1121919
·
Received August 13, 2008
Report
- Report Number
- 3005075853-2008-01179
- Event Type
- Malfunction
- Date Received
- August 13, 2008
- Date of Event
- July 23, 2008
- Report Date
- July 30, 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
- SC, 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 THE DEVICE WERE USED DURING A LAPAROSCOPIC APPENDECTOMY. DOCTOR ATTEMPTED TO FIRE THE FIRST DEVICE AND THE HANDLE WOULD NOT SQUEEZE TOGETHER TO FIRE STAPLES. THE SECOND DEVICE WAS OPENED AND LOADED WITH A NEW RELOAD. CARTRIDGE CAME OUT OF THE DEVICE WHEN ATTEMPTING TO FIRE THE STAPLES. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETS FLEX ARTICNG LNR CUTR 45MM | GDW | ETHICON ENDO-SURGERY, LLC | NA | E4LA90 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |