BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE ADENOID TIP

    MDR report key: 6213134 · Received December 29, 2016

    Report

    Report Number
    1226420-2016-00198
    Event Type
    Malfunction
    Date Received
    December 29, 2016
    Date of Event
    November 23, 2016
    Report Date
    November 30, 2016
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT INFORMATION UNABLE TO BE OBTAINED DESPITE A GOOD FAITH EFFORT MADE TO OBTAIN THE INFORMATION FROM THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AFTER THE ENT SURGERY WAS COMPLETED, THE SURGEON REPORTED THE RIGHT SIDE OF THE PLASTIC HOUSING ON THE PLASMABLADE DEVICE MELTED. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862134 PLASMABLADE ADENOID TIP ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC PS300-003 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1