BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTX VASERLIPO SYSTEM

    MDR report key: 11690601 · Received April 19, 2021

    Report

    Report Number
    3011423170-2021-00042
    Event Type
    Injury
    Date Received
    April 19, 2021
    Date of Event
    March 18, 2021
    Report Date
    March 23, 2021
    Manufacturer
    SOLTA MEDICAL
    Product Code
    MUU
    PMA / PMN Number
    K110306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY FILE WAS REVIEWED AND FOUND FINAL TEST VERIFICATION SPECIFICATIONS ACCEPTABLE. THERE WERE NO NON-CONFORMITIES OR ANOMALIES FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD FOR SERIAL/LOT NUMBER BBC2MY. SERVICE CONFIRMED THE SUCTION WAS LOW BECAUSE OF A CRACK IN THE 90 DEGREE ELBOW ABOVE THE FILTER. IT IS UNKNOWN HOW THE CRACK OCCURRED. VASERLIPO RISK ASSESSMENT (260-0113HZ REV. 12) STATES POSSIBLE DELAY IN TREATMENT CAN OCCUR IF SUCTION IS NOT OPERATING AS USUAL. SERVICE REMOVED AND REPLACED THE 90 DEGREE ELBOW (P/N 410-0151). A FILTER WAS INSTALLED AND THE SYSTEM WAS TESTED. IT NOW PULLS -23MMHG. THE REST OF THE SYSTEM WAS ALSO FULLY TESTED. THE SYSTEM NOW WORKS AS EXPECTED. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. TRENDING WILL BE PERFORMED TO MONITOR THIS ISSUE. NO FURTHER ACTION OR CORRECTIVE ACTION REQUIRED. THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED RATHER EVALUATED AND SERVICED ON SITE. THE EVALUATION CONFIRMED THE SUCTION WAS LOW BECAUSE OF A CRACK IN THE 90 DEGREE ELBOW ABOVE THE FILTER. THE TECHNICIAN REMOVED AND REPLACED THE 90 DEGREE ELBOW. THEY INSTALLED THE FILTER AND FULLY TESTED THE SYSTEM, WHICH IS NOW WORKING AS EXPECTED. IT WAS CONFIRMED THAT THERE WAS NO INJURY TO THE PATIENT. THE INVESTIGATION IS UNDERWAY. ADDITIONAL INVESTIGATION RESULTS ARE PENDING.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED HAVING A PATIENT UNDER GENERAL ANESTHESIA WHEN THE VENTX WAS TURNED ON WOULD NOT HOLD SUCTION. THE SYSTEM WAS NOT TESTED BEFORE THE PROCEDURE, AND THERE WAS A CRACK IN THE ELBOW CONNECTION PIECE TO THE FILTER. THE USER FACILITY WAS ABLE TO COMPLETE THE PROCEDURE BY SWITCHING TO ANOTHER LIPOSUCTION MACHINE, BUT THE PATIENT WAS UNDER GENERAL ANESTHESIA MORE THAN 15 MINUTES LONGER THAN NORMAL DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584886 VENTX VASERLIPO SYSTEM SYSTEM, SUCTION, LIPOPLASTY MUU SOLTA MEDICAL 110-0022 222

    Patients

    Seq Age Sex Outcome Treatment
    1 Other