BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASERLIPO SYSTEM

    MDR report key: 17725259 · Received September 11, 2023

    Report

    Report Number
    3011423170-2023-00080
    Event Type
    Injury
    Date Received
    September 11, 2023
    Report Date
    July 25, 2023
    Manufacturer
    SOLTA MEDICAL, INC
    Product Code
    QPB
    PMA / PMN Number
    K190551
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AND EVALUATED. SERVICE WAS ABLE TO CONFIRM THAT THE HANDPIECE IS INOPERABLE. THE HANDPIECE FAILED THE WAVEFORM, CONTINUITY AND FUNCTIONAL TESTING. IT IS UNKNOWN WHAT CAUSED THE FAILURE OF HANDPIECE. DELAYED PROCEDURE DUE TO INOPERABLE HANDPIECE AND SYSTEM IS IDENTIFIED IN THE VASERLIPO SYSTEM RISK ASSESSMENT. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. NO NON-CONFORMITIES OR ANOMALIES FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD. BASED ON THE AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED, AND NO CONCLUSIONS CAN BE FOUND. NO CORRECTIVE ACTION IS NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED A DELAY TO A VASERLIPO PROCEDURE THAT WAS ABOUT 1 HOUR AND 20 MINUTES WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE DELAY WAS CAUSED BY THE VASERLIPO HANDPIECE BEING INOPERABLE. THE TREATING PHYSICIAN REPORTED THAT HE WAS ABLE TO COMPLETE THE PROCEDURE WITH ANOTHER HANDPIECE, WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138408 VASERLIPO SYSTEM SYSTEM, SUCTION, LIPOPLASTY FOR REMOVAL QPB SOLTA MEDICAL, INC VHP

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown