BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE 3.0 WIDE SPATULA

    MDR report key: 3451382 · Received November 6, 2013

    Report

    Report Number
    1226420-2013-00183
    Event Type
    Malfunction
    Date Received
    November 6, 2013
    Date of Event
    October 7, 2013
    Report Date
    October 7, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    DWG
    PMA / PMN Number
    K093695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (METHOD): (RESULTS): (CONCLUSION): DEVICE DISCARDED AFTER USE THEREFORE ANALYSIS UNABLE TO BE PERFORMED. (B)(6).

    Description of Event or Problem · 1

    PRIOR TO ACTIVATING THE DEVICE THE CUSTOMER PLUGGED IN THE DEVICE TO THE GENERATOR AND RECEIVED AN ERROR CODE STATING THE DEVICE HAD REACHED END OF LIFE. PURCHASER CALLED SALES REP AND CONFIRMED VIA TELEPHONE WITH REP LISETTTE, THE PRODUCT WAS REPROCESSED BY ANOTHER COMPANY. CUSTOMER DISCARDED THE DEVICE AND USED PRODUCT PURCHASED DIRECTLY FROM MAE TO SUCCESSFULLY COMPLETE THE CASE. NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573900 PLASMABLADE 3.0 WIDE SPATULA ELECTROSURGICAL DEVICE DWG MEDTRONIC ADVANCED ENERGY, LLC PS210-030S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1