BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR II

    MDR report key: 2808741 · Received October 30, 2012

    Report

    Report Number
    3007069406-2012-00506
    Event Type
    Malfunction
    Date Received
    October 30, 2012
    Date of Event
    October 5, 2013
    Report Date
    March 25, 2013
    Manufacturer
    PEAK SURGICAL
    Product Code
    MUL
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT# (B)(4), EVALUATION PROCESS: UNIT RECEIVED IN FAIR CONDITION AND INTERNAL VISUAL INSPECTION REVEALED NO LOOSE OR BROKEN COMPONENTS. UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS. ROOT CAUSE: UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS USING TEST BLADES WITH NO ISSUES IN THE SERVICE DEPARTMENT. (B)(4).

    Description of Event or Problem · 1

    PLASMABLADE STOPPED WORKING. SURGEON SWITCHED TO ELECTRO CAUTERY TO COMPLETE CASE.

    Description of Event or Problem · 1

    PLASMABLADE STOPPED WORKING MID-PROCEDURE. SURGEON SWITCHED TO ELECTROCAUTERY TO COMPLETE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAR II GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER MUL PEAK SURGICAL PS100-102

    Patients

    Seq Age Sex Outcome Treatment
    1