BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 3833241 · Received May 27, 2014

    Report

    Report Number
    3005075853-2014-03556
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 1, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE PSE60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH ONE ECR60G CARTRIDGE LOADED ON THE DEVICE. THE RELOAD WAS RECEIVED UNFIRED AND IN GOOD VISUAL CONDITION. DURING FURTHER EVALUATION, THE DEVICE WAS NOTED TO BE NON FUNCTIONAL. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING, THE MOTOR WAS FOUND TO BE NON-FUNCTIONAL. PLEASE NOTE THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE RETURNED CONDITION OF THE DEVICE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE FIRED THREE TIMES AND THEN THE BATTERY STOPPED WORKING. THERE WAS NO PATIENT IMPACT OR DELAY IN PROCEDURE AS A RESULT. THESE ARE ALL THE DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311482 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L90E62

    Patients

    Seq Age Sex Outcome Treatment
    1