BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMAKINETIC SUPERPULSE SYSTEM

    MDR report key: 2875188 · Received December 5, 2012

    Report

    Report Number
    2875188
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    November 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    GYRUS ACMI
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DEVICE DID NOT FUNCTION - IT DID NOT CAUTERIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMAKINETIC SUPERPULSE SYSTEM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI GYRUS ACMI SUPERLOOP PK FRONT LOADING ELECTRODE U1207144

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR NO OTHER THERAPIES