BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR PULSAR2

    MDR report key: 2981282 · Received February 27, 2013

    Report

    Report Number
    1226420-2013-00044
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 31, 2013
    Report Date
    April 26, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    MUL
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT #(B)(4) EVALUATION PROCESS: UNIT RECEIVED IN FAIR CONDITION WITH VERY MINOR SURFACE IMPERFECTIONS. INTERNAL VISUAL INSPECTION REVEALED NO LOOSE OR BROKEN COMPONENTS. UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS. TO ESTABLISH THAT THE UNIT DELIVERED ENERGY CORRECTLY IN CUT AND COAG MODES, THE ACTIVE BURN-IN PORTION OF TEST PROCEDURE TP-0048 WAS PERFORMED. THE UNIT PASSED WITH NO ISSUES ROOT CAUSE: UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS IN THE SERVICE DEPARTMENT. (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

    SHORTLY INTO CASE THE COAG DIMINISHED IN CAPABILITY TO CUT OR COAG. SWITCHED TO STANDARD ELECTROCAUTERY.

    Description of Event or Problem · 1

    SHORTLY INTO CASE THE COAG DIMINISHED IN CAPABILITY TO CUT OR COAG. SWITCHED TO STANDARD ELECTROCAUTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83730 GENERATOR PULSAR2 GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER MUL MEDTRONIC ADVANCED ENERGY, LLC PS100-102

    Patients

    Seq Age Sex Outcome Treatment
    1