BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASERLIPO SYSTEM

    MDR report key: 16126904 · Received January 9, 2023

    Report

    Report Number
    3011423170-2023-00002
    Event Type
    Injury
    Date Received
    January 9, 2023
    Date of Event
    December 12, 2022
    Report Date
    December 12, 2022
    Manufacturer
    SOLTA MEDICAL, INC
    Product Code
    QPB
    PMA / PMN Number
    K170758
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED AND EVALUATED. SERVICE WAS UNABLE TO CONFIRM THE COMPLAINT. THE OUTPUT OF THE SYSTEM PERFORMED WITHIN SPECIFICATION. A HANDPIECE WAS CONNECTED TO THE SYSTEM AND A WEAK SOUND WAS EMITTED WHEN COMPARED TO WHEN THE HANDPIECE WAS FIRST ACTIVATED. EVEN THOUGH THE SOUND WAS WEAK, ALL MEASUREMENTS ARE WITHIN SPECIFICATIONS. A PLANT EVALUATION IS UNDERWAY.

    Additional Manufacturer Narrative · 0

    CORRECTION:  D1 BRAND NAME - FROM: VASER PRO AMPLIFIER -  TO: VASERLIPO SYSTEM.  D2 COMMON DEVICE NAME -  FROM: ULTRASONIC SURGICAL SYSTEM GENERATOR -  TO: SYSTEM, SUCTION, LIPOPLASTY.  D2: PRODUCT CODE - FROM:  MUU TO: QPB. G4: PMA 510K FROM: K110306- TO: K170758. THE VASER SYSTEM WAS RETURNED FOR EVALUATION. SERVICE DID NOT VERIFY WEAK SIGNAL OR OUTPUT FROM THE SYSTEM. ACCORDING TO THE VASERLIPO SAFETY RISK ASSESSMENT, NO ULTRASOUND FUNCTION CAN CAUSE A DELAY IN TREATMENT. A REVIEW OF THE MANUFACTURING RECORDS SHOWED ALL REQUIREMENTS WERE MET. 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. BASED ON THE AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED, AND NO CONCLUSIONS CAN BE DRAWN. NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED THAT A TREATMENT WAS CANCELLED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. IT WAS REPORTED THAT THERE WAS LOW OUTPUT WITH A WEAK SIGNAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205030 VASERLIPO SYSTEM SYSTEM, SUCTION, LIPOPLASTY QPB SOLTA MEDICAL, INC 110-0032
    787929 VASERLIPO SYSTEM SYSTEM, SUCTION, LIPOPLASTY QPB SOLTA MEDICAL, INC 110-0032

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown