FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER - 3.5 MM - STANDARD
MDR report key: 1080019
·
Received July 17, 2008
Report
- Report Number
- 3005075853-2008-00571
- Event Type
- Malfunction
- Date Received
- July 17, 2008
- Date of Event
- June 23, 2008
- Report Date
- June 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
D4; H4, 6: INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED BY THE AFFILIATE THAT DURING A WEDGE RESECTION PROCEDURE, THE CARTRIDGE FELL INTO THE PATIENT'S BODY DURING THE SECOND FIRING. AS A RESULT, THE LUNG PARENCHYMA WAS DAMAGED BY A FEW MILLIMETERS. IT IS NOT KNOWN IF AND HOW IT WAS REPAIRED. THE FALLEN CARTRIDGE WAS REMOVED. THE DEVICE WAS CUT SLIGHTLY. 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 | ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER - 3.5 MM - STANDARD | GDW | ETHICON ENDO-SURGERY, LLC. | NA | A4AU86 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |