BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASERLIPO SYSTEM

    MDR report key: 16312106 · Received February 7, 2023

    Report

    Report Number
    3011423170-2023-00016
    Event Type
    Injury
    Date Received
    February 7, 2023
    Date of Event
    January 6, 2023
    Report Date
    January 6, 2023
    Manufacturer
    SOLTA MEDICAL INC.
    Product Code
    QPB
    PMA / PMN Number
    K190551
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FIELD SERVICE WAS ABLE TO CONFIRM THE ISSUE. THE A/C CONTROL BOARD INSIDE THE DEVICE WAS BURNT AND UNSERVICEABLE. THE CAUSE OF THIS EVENT WAS TRACED TO A COMPONENT FAILURE. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. FINAL TEST VERIFICATION SPECIFICATIONS ARE ACCEPTABLE. NO NON-CONFORMITIES OR ANOMALIES FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD. NO CORRECTIVE ACTION IS REQUIRED. TRENDING WILL BE PERFORMED TO MONITOR THIS ISSUE.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED THAT DURING A VASERLIPO PROCEDURE, SMOKE STARTED COMING OUT OF THE VASER PRO CONSOLE, WHICH RESULTED IN A DELAY GREATER THAN ONE HOUR WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. IT WAS REPORTED THAT A VENTX WAS USED, AND THAT ONCE THE SYSTEM WAS TURNED ON (BEFORE ACTIVATING SUCTION), AN ODD NOISE OCCURRED WITH A BURNING SMELL. AT THAT POINT, SMOKE STARTED TO COME OUT OF THE BACK OF THE BASE. THE SYSTEM WAS NOT TESTED BEFORE THE PROCEDURE. THE SYSTEM WAS TURNED ON, BUT SUCTION WAS NOT ACTIVATED. THE PATIENT WAS ALREADY UNDER ANESTHESIA WHEN THE SYSTEM WAS TESTED. THE TREATMENT WAS NOT COMPLETED USING THE VASER. HOWEVER, TREATMENT WAS COMPLETED USING ANOTHER TOWER, WHICH CONTRIBUTED TO THE DELAY- AS THE DOCTOR HAD TO WAIT FOR THE AVAILABILITY OF THE MACHINE. NO INJURY WAS REPORTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107671 VASERLIPO SYSTEM SYSTEM, SUCTION, LIPOPLASTY QPB SOLTA MEDICAL INC. 110-0022

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown