BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1253025 · Received December 9, 2008

    Report

    Report Number
    1527736-2008-03478
    Event Type
    Malfunction
    Date Received
    December 9, 2008
    Report Date
    May 13, 2008
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/04/2008. THE ANALYSIS RESULTS SHOWED THAT ONE DEVICE WAS RETURNED IN WITH THE HANDLES OPEN AND WITH NO CARTRIDGE PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED; HOWEVER, THE CUT WAS NOTED TO BE JAGGED DUE TO A DAMAGED KNIFE, THIS DAMAGED IS CONSISTENT WHEN THE DEVICE IS FIRED OVER AND ALREADY EXISTING STAPLE LINE, HARD OBJECT OR THICKER TISSUE THAN INDICATED. EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE ACHIEVED A COMPLETE FIRING CYCLE AND THE STAPLES WERE NOTED TO HAVE A B-FORMED SHAPE. IT SHOULD BE NOTED A 100% INSPECTION TAKES PLACE DURING MFG TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENTS, IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT FGQA. THE MFG RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP GASTRIC BYPASS PROCEDURE, IN THE FIRST FIRING STROKE, THE PRESSURE TO FIRE IS GREATER AND THE FEELING WITHIN THE FIRING HANDLE FEELS GRIDDY WITH INCREASE FORCE TO FIRE. THE SURGEON USES A HEMOSTAT CALLED NUKNIT. 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 NONE GDW ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4JF11

    Patients

    Seq Age Sex Outcome Treatment
    1