BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE 4.0 GENERAL SURGERY

    MDR report key: 3010770 · Received March 19, 2013

    Report

    Report Number
    1226420-2013-00071
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 19, 2013
    Report Date
    April 2, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    DWG
    PMA / PMN Number
    K073057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT # (B)(4) TESTING PERFORMED: VISUAL INSPECTION DEVICES: PEAK PLASMABLADE 4.0 PRODUCT P/N: PS200-040 RGA# 700252642-POR LOT# 58031 QTY: 1 EXPIRATION DATE: 2015/09 RETURNED IN (B)(4) EXPRESS ENVELOPE DEVICE WAS RETURNED IN DOUBLE BIOHAZARD BAGS, SEALED. TYVEK LID WAS INCLUDED. LIDS INDICATE THE DEVICE CAME FROM LOT 58031 AND EXPIRE 2015/09. DEVICE APPEARS TO HAVE BEEN USED, AS THERE IS BLOOD PLATTER ON THE DEVICE. NOTHING APPEARED TO BE DAMAGED ON THE DEVICES. ALL COMPONENTS WERE INTACT. FUNCTIONAL INSPECTION DEVICE WAS CONNECTED TO A PULSAR II GENERATOR (PS100-102), EQP# (B)(4) (CALIBRATION DUE DATE: 09/2013) DEVICE SHOWED THE 'E5 ERROR CODE - MONO-POLAR HANDPIECE HAS REACHED END OF LIFE' WHEN CONNECTED TO THE GENERATOR. THE BYPASS CONNECTOR WAS USED TO TEST THE FUNCTIONALITY OF THE DEVICE. THE DEVICE WAS ACTIVATED IN GROUNDED SALINE AT CUT SETTING 10 AND COAG SETTING 10. THIS TEST YIELDED EXPECTED RESULTS. DUE TO THE INABILITY TO REPLICATE THE COMPLAINT IN GROUNDED SALINE, THE DEVICE WAS TESTED WITH CHICKEN BREAST. THE BYPASS CONNECTOR WAS AGAIN USED TO TEST FUNCTIONALITY OF THE DEVICE. THE DEVICE WAS ACTIVATED IN CHICKEN BREAST FOR 2.5 MINUTES AT CUT SETTING 5, 2.5 MINUTES AT CUT SETTING 10, AND 5 MINUTES AT COAG SETTING 10. THIS TEST PRODUCED ACCEPTABLE RESULTS. INVESTIGATION CONCLUSION: THE COMPLAINT WAS NOT CONFIRMED FOR THIS DEVICE. EVALUATION OF THE DEVICE USING A PULSAR II GENERATOR AND BYPASS CONNECTOR, IN BOTH GROUNDED SALINE AND CHICKEN BREAST, YIELDED ACCEPTABLE RESULTS. THE DEVICE FUNCTIONED AS INTENDED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) METHOD: PRODUCT RECEIVED BY MANUFACTURER AND PENDING INSPECTION. RESULTS: PRODUCT RECEIVED BY MANUFACTURER AND PENDING INSPECTION. CONCLUSION: PRODUCT RECEIVED BY MANUFACTURER AND PENDING 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

    DURING THE CASE THE GENERATOR ERRORED THAT IT WENT INTO RF LEAKAGE MITIGATION MODE AND THE SYSTEM THEN FAILED TO CUT OR COAGULATE TISSUE. THE GENERATOR WAS SWAPPED OUT AND THE CASE CONTINUED.

    Description of Event or Problem · 1

    GENERATOR WENT INTO RF LEAKAGE MITIGATION MODE AND SYSTEM FAILED TO CUT OR COAG TISSUE, GENERATOR HAD TO BE SWAPPED OUT FOR THE PROCEDURE TO CONTINUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113174 PLASMABLADE 4.0 GENERAL SURGERY ELECTROSURGICAL DEVICE DWG MEDTRONIC ADVANCED ENERGY, LLC PS200-040 58031

    Patients

    Seq Age Sex Outcome Treatment
    1