BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR II GENERATOR

    MDR report key: 2831414 · Received November 14, 2012

    Report

    Report Number
    1226420-2012-00069
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 24, 2012
    Report Date
    January 23, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    MUL
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT #700171879 EVALUATION PROCESS: UNIT RECEIVED IN GOOD CONDITION AND INTERNAL VISUAL INSPECTION REVEALED NO LOOSE OR BROKEN COMPONENTS. COAG DOES NOT WORK WHEN PRESSING BLADE HANDPIECE BUTTON AND IT WAS FOUND THAT RED WIRE (COAG SWITCH) IN THE INTERNAL MONOPOLAR CABLE HARNESS WAS READING OPEN CIRCUIT. AFTER REPLACING MONOPOLAR CABLE HARNESS THE UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS. ERROR LOG: NO ERRORS. ROOT CAUSE: THE RED WIRE IN THE MONOPOLAR CABLE HARNESS WAS FOUND TO BE IN OPEN-CIRCUIT FOR UNKNOWN REASONS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL METHOD: PRODUCT SCHEDULED FOR RETURN BUT NOT RECEIVED BY MANUFACTURER FOR INSPECTION. RESULTS AND CONCLUSION: PRODUCT SCHEDULED FOR RETURN BUT NOT RECEIVED BY MANUFACTURER FOR INSPECTION. (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

    PULSAR II GENERATOR FAILED TO COAG. SAME ISSUE OCCURRED UPON OPENING A SECOND DEVICE SO SURGERY WAS COMPLETED BY SWITCHING TO ELECTROCAUTERY.

    Description of Event or Problem · 1

    PULSAR II GENERATOR FAILED TO COAG. SAME ISSUE OCCURRED UPON OPENING A SECOND DEVICE SO SURGERY WAS COMPLETED BY SWITCHING TO ELECTROCAUTERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1