FDA Adverse Event
Malfunction
Summary report: N
ETS AND ETS-FLEX ARTICULATING ENDOSCOPIC LINEAR CUTTER RELOADS - 35 MM VASCULAR
MDR report key: 1210263
·
Received October 21, 2008
Report
- Report Number
- 3005075853-2008-02486
- Event Type
- Malfunction
- Date Received
- October 21, 2008
- Date of Event
- September 25, 2008
- Report Date
- September 26, 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
- JA
- 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 DURING A LOBECTOMY PROCEDURE, WHEN THE SURGEON EXCHANGED THE CARTRIDGE, HE FOUND THE PROXIMAL PART OF THE PAN WAS LOOSE FITTING WITH THE CARTRIDGE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETS AND ETS-FLEX ARTICULATING ENDOSCOPIC LINEAR CUTTER RELOADS - 35 MM VASCULAR | GDW | ETHICON ENDO-SURGERY, LLC | NA | E4L99M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |