BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENCO LINEAR CUTTER

    MDR report key: 1823919 · Received January 16, 2008

    Report

    Report Number
    1527736-2008-00306
    Event Type
    Malfunction
    Date Received
    January 16, 2008
    Date of Event
    June 26, 2007
    Report Date
    June 28, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DAMAGED SHROUDS. EVALUATION SUMMARY: THE ANALYSIS RESULTS SHOWED THAT ONE DEVICE WAS REC'D 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. AFTER FURTHER ANALYSIS, IT WAS NOTED THAT THE DEVICE FIRING MECHANISM WAS NOTED TO BE DAMAGED, AS THE FIRING TRIGGER DID NOT RETURN TO ITS HOME POSITION AFTER EACH STROKE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE LEFT SIDE RELEASE BUTTON POST WAS NOTED TO BE BROKEN. EVEN THOUGH THE RELEASE BUTTON IS NOT PART OF THE FIRING MECHANISM, WHEN IT BREAKS IT CREATES FRICTION TO THE FIRING TRIGGER NOT ALLOWING THE TRIGGER TO PROPERLY RETURN TO ITS HOME POSITION. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE HANDLE BECAME OPEN, IT SHOULD BE NOTED THAT A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT, IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4). THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, THE FIRING TRIGGER WAS BROKEN. THEY USED ANOTHER LIKE DEVICE TO COMPLETE THE CASE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 ENCO LINEAR CUTTER GDW ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4H83F

    Patients

    Seq Age Sex Outcome Treatment
    1