FDA Adverse Event
Malfunction
Summary report: N
ETS FLEX ARTICNG LNR CUTR 45MM
MDR report key: 1162321
·
Received September 8, 2008
Report
- Report Number
- 3005075853-2008-01584
- Event Type
- Malfunction
- Date Received
- September 8, 2008
- Date of Event
- August 18, 2008
- Report Date
- August 19, 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
- CA, 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 HAND ASSISTED LAP COLON PROCEDURE, THE FIRST DEVICE CUT BUT DID NOT STAPLE. THEY GOT A NEW DEVICE AND IT FIRED THE FIRST AND SECOND RELOAD FINE. ON THE THIRD RELOAD, THE CARTRIDGE SPIT OUT OF THE DEVICE AND FELL INTO THE PT. THEY RETRIEVED THE CARTRIDGE. A THIRD DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETS FLEX ARTICNG LNR CUTR 45MM | GDW | ETHICON ENDO-SURGERY, LLC | NA | E4LJ32 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |