BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASERLIPO SYSTEM

    MDR report key: 11974027 · Received June 10, 2021

    Report

    Report Number
    3011423170-2021-00057
    Event Type
    Injury
    Date Received
    June 10, 2021
    Date of Event
    May 18, 2021
    Report Date
    May 18, 2021
    Manufacturer
    BAUSCH + LOMB
    Product Code
    MUU
    PMA / PMN Number
    K110306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE MANUFACTURING RECORDS SHOWED REQUIREMENT WERE MET. NO PATIENT INJURY OCCURRED, BUT PATIENT TREATMENT WAS DELAYED BY MORE THAN 15 MINUTES WHILE UNDER GENERAL ANESTHESIA. SERVICE CONFIRMED INOPERABLE VHP, ONE OF THE PZT WASHER WAS CRACKED CAUSING HANDPIECE NOT TO DELIVER ENOUGH ENERGY TO PROBE. THE ULTRASONIC FREQUENCY VIBRATION WAS CREATED USING THE PIEZOELECTRIC PROPERTY OF PZT CERAMIC CRYSTALS LOCATED IN THE VASER HANDPIECE. BASED ON THE AVAILABLE INFORMATION THIS EVENT WAS RELATED TO THE CRACKED PZT WASHER. THE HANDPIECE WAS NOT REPAIRABLE. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. NO CORRECTIVE ACTION REQUIRED.

    Additional Manufacturer Narrative · 0

    THE PRODUCT EVALUATION CONFIRMED THE VASER HANDPIECE WAS INOPERABLE. ONE OF THE PZT WASHER WAS CRACKED CAUSING THE HANDPIECE TO NOT DELIVER ENOUGH ENERGY TO PROBE. THE HANDPIECE WAS NOT REPAIRABLE. THE FINAL TEST VERIFICATION SPECIFICATIONS WERE ACCEPTABLE. NO NON-CONFORMITIES OR ANOMALIES FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD FOR SERIAL/LOT NUMBER BBCJNH.

    Additional Manufacturer Narrative · 1

    FINAL TEST VERIFICATION SPECIFICATIONS ARE ACCEPTABLE. NO NON-CONFORMITIES OR ANOMALIES FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD FOR SERIAL/LOT NUMBER (B)(4). INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE VASER HANDPIECE WAS INOPERABLE. THE POWER WAS NOT WORKING AND THEN STOPPED AFTER 5 MINUTES. THEY REPLACED THE FOOT PEDALS WITH A WIRED FOOT PEDAL AND IT STILL DID NOT WORK. THE ULTRASOUND LIGHT WAS SHOWING IT WAS ON, BUT THERE WAS NO ENERGY. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND THE TREATMENT WAS DELAYED MORE THAN 15 MINUTES. THE TREATMENT HAD TO BE ABORTED AND THE PATIENT WAS SENT HOME AS THEY COULD NOT CONTINUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869471 VASERLIPO SYSTEM SYSTEM, SUCTION, LIPOPLASTY MUU BAUSCH + LOMB VHP 222

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention