FDA Adverse Event
Malfunction
Summary report: N
ECHELON 60 ENDOPATH STAPLER
MDR report key: 1080333
·
Received July 24, 2008
Report
- Report Number
- 1527736-2008-00292
- Event Type
- Malfunction
- Date Received
- July 24, 2008
- Date of Event
- November 13, 2007
- Report Date
- June 27, 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
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 07/08/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAP SPLENECTOMY PROCEDURE, THE DEVICE FAILED TO OPEN AFTER CLOSURE OF THE JAWS. 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 | ECHELON 60 ENDOPATH STAPLER | NONE | GDW | ETHICON ENDO-SURGERY, LLC | NA | D4J225 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |