BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE 4.0 GENERAL SURGERY

    MDR report key: 3052031 · Received April 11, 2013

    Report

    Report Number
    1226420-2013-00100
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 11, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    DWG
    PMA / PMN Number
    K073057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (B)(4). METHOD: DEVICE DISCARDED THEREFORE UNABLE TO BE RETURNED FOR ANALYSIS. RESULT: DEVICE DISCARDED THEREFORE UNABLE TO BE RETURNED FOR ANALYSIS. CONCLUSION: DEVICE DISCARDED THEREFORE UNABLE TO BE RETURNED FOR ANALYSIS. (B)(4).

    Description of Event or Problem · 1

    AFTER A FEW MINUTES OF CUT AND/OR COAGULATION MODE ACTIVATION OF PULSAR GENERATOR AND PLASMABLADE THE AMPLIFIER ON THE EKG MACHINE BECOMES SATURATED AND LOCKS UP. EKG MACHINE HAS TO BE SHUT DOWN AND RESTARTED. PULSAR AND PLASMABLADE WERE USED FOR THE ENTIRETY OF THE CASE, WHICH WAS COMPLETED SUCCESSFULLY, EKG MACHINE JUST RE-BOOTED TO PROCEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154448 PLASMABLADE 4.0 GENERAL SURGERY ELECTROSURGICAL DEVICE DWG MEDTRONIC ADVANCED ENERGY, LLC PS200-040

    Patients

    Seq Age Sex Outcome Treatment
    1