FDA Adverse Event
Malfunction
Summary report: N
ECHELON 60 ENDOPATH STAPLER
MDR report key: 1121901
·
Received August 13, 2008
Report
- Report Number
- 3005075853-2008-01151
- Event Type
- Malfunction
- Date Received
- August 13, 2008
- Date of Event
- July 29, 2008
- Report Date
- July 29, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GDW
- PMA / PMN Number
- K051002
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A THORACOTOMY PROCEDURE, THE DEVICE FIRED MALFORMED STAPLES ON THE FIRST FIRING ALONG THE LUNG. THE REST OF THE STAPLE LINES WERE FINE. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECHELON 60 ENDOPATH STAPLER | GDW | ETHICON ENDO-SURGERY, LLC | NA | E4KG6P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |