FDA Adverse Event
Injury
Summary report: N
ECHELON 60 ENDOPATH STAPLER
MDR report key: 1030071
·
Received April 15, 2008
Report
- Report Number
- 1527736-2008-02237
- Event Type
- Injury
- Date Received
- April 15, 2008
- Date of Event
- March 20, 2008
- Report Date
- March 27, 2008
- Manufacturer
- ETHICON ENDO SURGERY, INC. (CINCINNATI)
- Product Code
- GDW
- PMA / PMN Number
- K051002
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 04/15/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LUNG RESECTION, AFTER THE SIXTH SUCCESSFUL FIRING, THE BLADE WOULD NOT RETURN INTO THE HOUSING OF THE DEVICE. DESPITE REPEATEDLY TRYING THE MANUAL RELEASE MECHANISM, THE DEVICE WOULD STILL NOT RELEASE FROM THE LUNG TISSUE. AS A RESULT, A COMPETITOR'S DEVICE WAS USED TO TRANSECT AROUND IN ORDER TO FREE THE INSTRUMENT FROM THE LUNG TISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECHELON 60 ENDOPATH STAPLER | GDW | ETHICON ENDO SURGERY, INC. (CINCINNATI) | NA | E4KF4N |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |