BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASERLIPO SYSTEM

    MDR report key: 3835995 · Received May 13, 2014

    Report

    Report Number
    3004106598-2014-00003
    Event Type
    Injury
    Date Received
    May 13, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 14, 2014
    Manufacturer
    SOLTA MEDICAL INC.
    Product Code
    OHV
    PMA / PMN Number
    K110306
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS RECEIVED FOR EVAL. THE SYSTEM WAS POWERED UP, COMPLETED ITS SELF-TEST AND WENT INTO STANDBY MODE. CONFIRMED THAT THE WIRELESS FOOTSWITCH WAS NOT FUNCTIONING, AND THE PT FLUID MONITORING SYSTEM (PFMS) MODULE AND SECONDARY VACUUM DISPLAY DID NOT POWER ON AS NO POWER WAS GOING TO THE PFMS MAST (PFMS MAST DISTRIBUTES POWER TO THE FOOT SWITCH RECEIVER, VACUUM DISPLAY AND PFMS). USING THE WIRED FOOTSWITCH CONFIRMED THE INFILTRATION PUMP FUNCTIONED IN BOTH DIRECTIONS AND ABLE TO ADJUST THE SPEED OF THE PUMP, HOWEVER THE PFMS DISPLAY WAS STILL NOT FUNCTIONAL. REMOVED THE PFMS MAST AND FOUND THE POWER HARNESS THAT SUPPLIES POWER TO THE MAST ASSEMBLY WAS REMOVED FROM THE POWER DISTRIBUTION BOARD. REINSTALLED THE HARNESS AND POWERED THE SYSTEM ON. THE WIRELESS FOOTSWITCH STAND BY LIGHT LIT AND THE SECONDARY VACUUM GAUGE AND PFMS MODULE TURNED ON. ADDITIONALLY, TESTED BOTH RETURNED VHP HAND PIECES AND THEY PERFORMED AS EXPECTED. AS STATED IN THE MANUAL, THE SAFE AND EFFECTIVE USE OF THIS MEDICAL DEVICE DEPENDS TO A LARGE DEGREE ON FACTORS SOLELY UNDER CONTROL OF THE OPERATOR.

    Description of Event or Problem · 1

    THE PT WAS PREPPED FOR A CIRCUMFERENTIAL LIPOSUCTION PROCEDURE. THE PT WAS ADMINISTERED MONITORED (MAC) ANESTHESIA AND INFILTRATED WITH LOCAL ANESTHESIA IN PLANNED INCISIONS AREA. THE PHYSICIAN MADE TWO SMALL SUBMENTAL STAB INCISIONS IN ORDER TO INFUSE THE TUMESCENT SOLUTION (A MIXTURE OF CRYSTALLOID, LOCAL ANESTHETIC AND EPINEPHRINE). AT THIS POINT, IT WAS DISCOVERED THE EQUIPMENT WAS NOT FUNCTIONAL; WIRELESS FOOT PEDAL INFILTRATION PORTION OF THE EQUIPMENT AND THE DISPLAY WERE NOT OPERATIONAL. ADDITIONALLY, CONNECTOR PIECES WERE MISSING SO UNABLE TO USE THE INFILTRATION CANNULA. MFR REPRESENTATIVE PRESENT IN THE CASE AND THE OPERATING ROOM STAFF ATTEMPTED TO TROUBLE-SHOOT FOR 30 MINUTES. THE PHYSICIAN ELECTED TO MOVE FORWARD WITH ALTERNATE TUMESCENT EQUIPMENT WHICH WAS AVAILABLE AT THE SURGICAL CENTER. DURING TROUBLESHOOTING OF THE EQUIPMENT THE MFR REPRESENTATIVE COMPROMISED THE STERILE FIELD AND ALL OF THE CONTAMINATED EQUIPMENT HAD TO BE REMOVED. DUE TO SURGICAL DELAY AND NON-FUNCTIONAL EQUIPMENT, THE PHYSICIAN DECIDED TO PERFORM STANDARD LIPOSUCTION USING THE SURGICAL CENTER'S EQUIPMENT. THE PROCEDURE TOOK 2 HOURS, INSTEAD OF THE SCHEDULED FOR 1 HOUR. SUBSEQUENTLY, TOWARDS THE END OF THE CASE, THE PT BEGAN HAVING A "PARADOXICAL REACTION TO THE ANAESTHESIA WHEREBY SHE WAS BECOMING RESTLESS AND AGITATED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285084 VASERLIPO SYSTEM SUCTION LIPOPLASTY SYSTEM OHV SOLTA MEDICAL INC. VASER-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other