BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASERLIPO SYSTEM

    MDR report key: 20102225 · Received August 29, 2024

    Report

    Report Number
    3011423170-2024-00203
    Event Type
    Injury
    Date Received
    August 29, 2024
    Report Date
    July 31, 2024
    Manufacturer
    SOLTA MEDICAL INC.
    Product Code
    QPB
    PMA / PMN Number
    K190551
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. A REPLACEMENT BUTTON ASSEMBLY WAS SENT TO A CONTRACT SERVICE REPRESENTATIVE IN ORDER TO REPAIR THE DEVICE. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    FIELD SERVICE EVALUATED THE SYSTEM AND CONFIRMED THE DAMAGED MODE BUTTON. IT IS UNKNOWN WHAT CAUSED THE DAMAGE. FIELD SERVICE REPLACED THE MODE BUTTON AND VASER BUTTON CABLE ASSEMBLY. AFTER REPAIRS, THE SYSTEM PASSED FUNCTIONAL AND ELECTRICAL SAFETY TESTS. NO PATIENT INJURY OCCURRED BUT IT WAS REPORTED THE PATIENT WAS UNDER PROLONGED ANESTHESIA FOR 60 MINUTES OR GREATER. DELAYED PROCEDURE DUE TO AN INOPERABLE SYSTEM IS IDENTIFIED IN THE VASERLIPO SYSTEM RISK ASSESSMENT. A REVIEW OF THE MANUFACTURING RECORDS SHOWED ALL REQUIREMENTS WERE MET. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. REVIEW OF MANUFACTURING RECORDS SHOW FINAL MANUFACTURING TEST VERIFICATION SPECIFICATIONS ARE ACCEPTABLE. NO NONCONFORMITIES OR ANOMALIES WERE FOUND RELATED TO THIS EVENT WHEN REVIEWING THE DEVICE HISTORY RECORD. BASED ON AVAILABLE INFORMATION THE DELAY IN SURGERY WAS CAUSED BY A DAMAGED MODE BUTTON. CAUSE OF THE DAMAGE COULD NOT BE DETERMINED. NO CORRECTIVE ACTION IS NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED THAT THE MODE BUTTON ON THEIR VASER AMPLIFIER STOPPED WORKING DURING A PROCEDURE. THE ISSUE OCCURRED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA AND THE PROCEDURE WAS CANCELLED. THERE WERE NO HEALTH CONSEQUENCES TO THE PATIENT, HOWEVER, THIS EVENT MEETS THE DEFINITION OF A SERIOUS INJURY PER SOLTA MEDICAL REVIEWER DUE TO THE ABORTED PROCEDURE AS WELL AS THE GREATER THAN ONE HOUR DELAY WHILE UNDER GENERAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356146 VASERLIPO SYSTEM SYSTEM, SUCTION, LIPOPLASTY QPB SOLTA MEDICAL INC. 110-0037

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown