BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR PULSAR REFURBISHED

    MDR report key: 2815618 · Received November 1, 2012

    Report

    Report Number
    1226420-2012-00056
    Event Type
    Malfunction
    Date Received
    November 1, 2012
    Date of Event
    October 18, 2012
    Report Date
    March 6, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    MUL
    PMA / PMN Number
    K073057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). EVAL, METHOD, RESULTS AND CONCLUSION: NOT SURE IF PRODUCTS ARE AVAILABLE FOR RETURN AND EVALUATION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) EVALUATION PROCESS: UNIT RECEIVED IN POOR CONDITION WITH ONE HANDPIECE. INTERNAL VISUAL INSPECTION REVEALED NO LOOSE OR BROKEN COMPONENTS. UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS. ERROR LOG: 11 E1 (BOTH HANDPIECE BUTTONS PUSHED SIMULTANEOUSLY), 11 E3 (PATIENT RETURN ELECTRODE HAS POOR CONNECTION), 2 E9 (MONOPOLAR OUTPUT ACTIVATED WITHOUT PATIENT RETURN ELECTRODE), 15 E11 (PATIENT RETURN ELECTRODE DISCONNECTED). ALL ERROR CODES ARE NORMAL USE ERRORS. UNIT WAS EVALUATED FOR PROPER FUNCTION OF HANDPIECE BUTTONS USING BOTH TEST FIXTURES AND SUPPLIED HANDPIECE. THE UNIT FUNCTIONED AS DESIGNED BOTH "CUT" AND "COAG" BUTTONS OPERATED THEIR RESPECTIVE FUNCTIONS WITH NO CROSSOVER. ROOT CAUSE: UNABLE TO REPRODUCE REPORTED PROBLEM IN SERVICE DEPARTMENT: UNIT FUNCTIONS CORRECTLY WITH BOTH TEXT FIXTURES AND RETURNED HANDPIECE. (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

    WHEN "CUT" BUTTON ON A PEAK PLASMABLADE WAS PUSHED, THE "COAG" FUNCTION WAS ACTIVATED AND VICE-VERSA. THE FUNCTION WAS OK, ONLY THAT THE BUTTONS ON THE DEVICE GAVE THE WRONG RESPONSE. NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    WHEN "CUT" BUTTON ON A PEAK PLASMABLADE WAS PUSHED, THE "COAG" FUNCTION WAS ACTIVATED AND VICE-VERSA. THE FUNCTION WAS OK, ONLY THAT THE BUTTONS ON THE DEVICE GAVE THE WRONG RESPONSE. NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENERATOR PULSAR REFURBISHED GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER MUL MEDTRONIC ADVANCED ENERGY, LLC PS100-100RF 11P01524

    Patients

    Seq Age Sex Outcome Treatment
    1