BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR2 GENERATOR REFURB

    MDR report key: 2867832 · Received December 11, 2012

    Report

    Report Number
    1226420-2012-00094
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 19, 2012
    Report Date
    February 5, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT #(B)(4). EVALUATION PROCESS: UNIT RECEIVED IN GOOD CONDITION AND INTERNAL VISUAL INSPECTION REVEALED NO LOOSE OR BROKEN COMPONENTS. UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS. TO ESTABLISH THAT UNIT DELIVERED RF ENERGY CORRECTLY IN CUT AND COAG MODES THE ACTIVE BURN-IN PORTION OF TEST PROCEDURE TP-0048 WAS PERFORMED AND THE UNIT PASSED WITH NO ISSUES. ERROR LOG: 40 E3 (PATIENT RETURN ELECTRODE HAD POOR CONNECTION), 4 E5 (MONOPOLAR HANDPIECE HAS REACHED END OF LIFE) AND BOTH ERRORS ARE CONSIDERED NORMAL USE ERRORS. ROOT CAUSE: COMPLAINT OF LOW/NO COAG OUTPUT POWER COULD NOT BE REPLICATED AS UNIT DELIVERED RATED POWER TO RATED LOADS IN THE SERVICE DEPARTMENT. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL METHOD, RESULTS AND CONCLUSION: PRODUCT SCHEDULED FOR RETURN BUT NOT RECEIVED BY MANUFACTURER FOR INSPECTION. PRODUCT EVENT: (B)(6).

    Description of Event or Problem · 1

    DEVICE STOPPED WORKING DURING CASE. COAG FUNCTION DIMINISHED UNTIL NO LONGER EFFECTIVE.

    Description of Event or Problem · 1

    DEVICE STOPPED WORKING DURING CASE. COAG FUNCTION DIMINISHED UNTIL NO LONGER EFFECTIVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1