FDA Adverse Event
Malfunction
Summary report: N
ETS-ENDOSCOPIC LINEAR CUTTER (VASCULAR/THIN)-35 MM
MDR report key: 1190743
·
Received October 7, 2008
Report
- Report Number
- 3005075853-2008-02162
- Event Type
- Malfunction
- Date Received
- October 7, 2008
- Report Date
- September 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
- NC, 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 THE DEVICE WAS USED DURING A NEPHRECTOMY. THE DEVICE CARTRIDGE BECAME DISLODGED AS THE DEVICE WAS FIRED. THE DEVICE FELL INTO THE PATIENT AND WAS RETRIEVED WITH GRASPERS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETS-ENDOSCOPIC LINEAR CUTTER (VASCULAR/THIN)-35 MM | GDW | ETHICON ENDO-SURGERY, LLC | NA | E4L63N |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |