FDA Adverse Event
Malfunction
Summary report: N
ECHELON 45 ENDOPATH STAPLER
MDR report key: 1210266
·
Received October 21, 2008
Report
- Report Number
- 3005075853-2008-02483
- Event Type
- Malfunction
- Date Received
- October 21, 2008
- Date of Event
- September 25, 2008
- Report Date
- October 14, 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
- HK
- 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 VATS LOBECTOMY PROCEDURE, A DEVICE FAILED. THE JAW OF THE STAPLER DID NOT OPEN UP WHEN THE RELEASE BUTTON WAS PUSHED. 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 | ECHELON 45 ENDOPATH STAPLER | NONE | GDW | ETHICON ENDO-SURGERY, LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |