BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIALITY¿ LIPOASPIRATE WASH SYSTEM

    MDR report key: 17603894 · Received August 23, 2023

    Report

    Report Number
    1651189-2023-05399
    Event Type
    Malfunction
    Date Received
    August 23, 2023
    Date of Event
    March 16, 2023
    Report Date
    August 23, 2023
    Manufacturer
    SIENTRA INC
    Product Code
    QKL
    PMA / PMN Number
    P070004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SIENTRA COMPLAINT #: (B)(4). SIENTRA RECEIVED THE SUSPECTED DEVICE FROM THE CUSTOMER AND PERFORMED A FAILURE ANALYSIS. IT WAS DETERMINED BY R&D THAT THE A-RING CAN BECOME TWISTED WHEN THE DEVICE WAS UNDER VACUUM OR CAN MOVE DURING SETUP/TRANSPORTATION. LOSS OF VACUUM OR INABILITY TO GENERATE VACUUM LEADS TO NO RISKS OF PATIENT SAFETY. THE GASKET DESIGN WAS UPDATED TO BE AN OFF THE SHELF ROUND A-RING INSTEAD OF A CUSTOM SQUARE GASKET. ENGINEERING STUDY WAS PERFORMED AND SHOWED IMPROVEMENT IN VACUUM CYCLING. NEW DESIGN WAS IMPLEMENTED ON 6/9/2023. SIENTRA WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    VIALITY UNIT DEVELOPED A CRACK THE LONG WAY DURING HARVESTING OF FAT. NO LEAKAGE OCCURRED, NEW UNIT OPENED AND FAT TRANSFERRED OVER TO NEW UNIT. PER SALES, THE SUCTION WAS SET TO HIGH ON THE MICRO AIRE UNIT AND THEY WERE USING A SIZE 4 HANDPIECE. THE SALES REP STATES THAT PRIOR TO THE CRACK THE SUCTION PRESSURE HAD BUILT DUE TO POSSIBLY A STUCK PIECE OF FAT IN THE SUCTION LINE AND HE SAW THE SIDES OF THE UNIT SUCK INWARDS PRIOR TO CRACKING. IT WAS ALSO STATED IT WAS A CLEAN CRACK WITH NO FRAGMENTS AND THEY WERE ABLE TO TRANSFER THE FAT FROM ONE DEVICE TO ANOTHER. TO COMPLETE THE SURGERY THE SURGEON SWITCHED TO A SIZE 5 CANNULA, TURNED DOWN THE SUCTION LEVEL ON THE MICRO AIRE UNIT AND CLEARED THE LINE MORE FREQUENTLY AND HAD NO FURTHER ISSUES PERFORMING FAT ASPIRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1483287 VIALITY¿ LIPOASPIRATE WASH SYSTEM FAT TRANSFER QKL SIENTRA INC RIP-S A41326

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female