BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEAK PULSAR II

    MDR report key: 2819307 · Received November 5, 2012

    Report

    Report Number
    1226420-2012-00057
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    September 28, 2012
    Report Date
    January 24, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    MUL
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT #(B)(4): EVALUATION PROCESS: UNIT RECEIVED IN POOR CONDITION AND INTERNAL VISUAL INSPECTION REVEALED NO LOOSE OR BROKEN COMPONENTS. WIRING FOR SENSE TRANSFORMER T9 OF RF BOARD WAS FOUND TO BE BACKWARDS AND WILL BE CORRECTED BUT THIS DID NOT AFFECT SYSTEM PERFORMANCE. UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS. ERROR LOG: 32 E3 (PATIENT RETURN ELECTRODE HAS POOR CONNECTION), 40 E5 (MONOPOLAR HANDPIECE HAS REACHED END OF LIFE), 15 E6 (MONOPOLAR HANDPIECE IS NOT RECOGNIZED AS A PEAK MONOPOLAR HANDPIECE OR HAS FAILED TESTING). ALL ERROR CODES ARE NORMAL USER ERRORS BUT THE HIGH FREQUENCY OF OCCURRENCE OF THE E5 AND E6 ERRORS SUGGESTS THAT THEY ARE A RESULT OF A KNOWN ISSUE WITH V4.0 SOFTWARE WHERE THE DATE AND TIME STAMP CAN BE WRITTEN OR READ INCORRECTLY LEADING TO E5 AND E6 ERRORS IF THE HANDPIECE IS UNPLUGGED AND THEN PLUGGED BACK IN. ROOT CAUSE: E5 AND E6 ERROR CODES IN THE LOG APPEAR TO BE DUE TO AN KNOWN ISSUE WITH V4.0 SOFTWARE WHERE THE DATE AND TIME STAMP CAN BE WRITTEN OR READ INCORRECTLY LEADING TO E5 AND E6 ERRORS IF THE HANDPIECE IS UNPLUGGED AND THEN PLUGGED BACK IN. THIS WILL BE ADDRESSED BY UPGRADING THE SOFTWARE TO V4.1. (B)(4).

    Additional Manufacturer Narrative · 1

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

    GENERATOR DID NOT RECOGNIZE DISPOSABLE, END OF LIFE ERROR DISPLAYED DURING SURGERY.

    Description of Event or Problem · 1

    GENERATOR DID NOT RECOGNIZE DISPOSABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1