BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENDOPATH STAPLER LONG ENDOSCOPIC LINEAR CUTTER- STRAIGHT 60 MM

    MDR report key: 1822237 · Received December 3, 2007

    Report

    Report Number
    1527736-2007-08182
    Event Type
    Malfunction
    Date Received
    December 3, 2007
    Date of Event
    November 8, 2007
    Report Date
    November 14, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP GASTRIC BYPASS PROCEDURE, THE DEVICE WOULD NOT FIRE. THE DEVICE WAS RELOADED AND IT TOOK MORE FORCE THAN USUAL TO FIRE. THE PROXIMAL END OF THE STAPLE LINE DID NOT STAPLE. SUTURES WERE USED TO CLOSE THE STAPLE LINE AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 ENDOPATH STAPLER LONG ENDOSCOPIC LINEAR CUTTER- STRAIGHT 60 MM GDW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1