BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR II GENERATOR

    MDR report key: 2981266 · Received February 27, 2013

    Report

    Report Number
    1226420-2013-00041
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 27, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    MUL
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: FACILITY DISPOSED OF DEVICE. DEVICE IS NOT AVAILABLE FOR RETURN AND INSPECTION. RESULTS: FACILITY DISPOSED OF DEVICE. DEVICE IS NOT AVAILABLE FOR RETURN AND INSPECTION. PRODUCT EVENT: (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    TIP FIRE UPON CONTACT WITH COMPRESS SOAKED WITH 50% ALCOHOL AND OTHER DISINFECTANTS. NO PATIENT INJURIES OR SYMPTOMS RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83863 PULSAR II GENERATOR GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER MUL MEDTRONIC ADVANCED ENERGY, LLC PS100-102

    Patients

    Seq Age Sex Outcome Treatment
    1