BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APOLLO SYSTEM GENERATOR

    MDR report key: 5054659 · Received September 3, 2015

    Report

    Report Number
    3005168196-2015-00859
    Event Type
    Malfunction
    Date Received
    September 3, 2015
    Date of Event
    August 4, 2015
    Report Date
    August 4, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    GWG
    PMA / PMN Number
    K132931
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE DEVICE IS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE USING AN APOLLO SYSTEM GENERATOR. UPON THE BEGINNING OF THE PROCEDURE, THE PHYSICIAN NOTICED THE APOLLO GENERATOR WAS NOT PRODUCING VIBRATIONAL ENERGY AND THE PROCEDURE WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584266 APOLLO SYSTEM GENERATOR GWG GWG PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR