BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIALITY¿ LIPOASPIRATE WASH SYSTEM

    MDR report key: 17272991 · Received July 6, 2023

    Report

    Report Number
    1651189-2023-05085
    Event Type
    Malfunction
    Date Received
    July 6, 2023
    Date of Event
    June 15, 2023
    Report Date
    June 15, 2023
    Manufacturer
    SIENTRA INC
    Product Code
    QKL
    UDI-DI
    00810076894621
    PMA / PMN Number
    BK190433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SIENTRA COMPLAINT #: (B)(4). PATIENT AGE DEFAULTED TO 99 AS NO PATIENT INFORMATION WAS PROVIDED. SIENTRA WAS UNABLE TO PERFORM AN EVALUATION AS THE DEVICE WAS DISCARDED BY THE CUSTOMER. SIENTRA WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. H3 OTHER TEXT : DEVICE DISCARDED

    Additional Manufacturer Narrative · 0

    SIENTRA COMPLAINT#: (B)(4). SIENTRA WAS ABLE TO PERFORM INVESTIGATION ON LOT/BATCH RETAINED BY THE MANUFACTURER AND 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 (B)(4) WAS PERFORMED AND SHOWED IMPROVEMENT IN VACUUM CYCLING. NEW DESIGN WAS IMPLEMENTED ON (B)(6) 2023. IT IS MOST LIKELY THE ROOT CAUSE WAS THE A-RING WAS OUT OF POSITION OR POSSIBLY TWISTED NOT ALLOWING FOR THE LID TO SIT FLUSH. THIS IS A KNOWN ISSUE AND HAS BEEN ADDRESSED. 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

    DOCTOR PERFORMED A RE-CONSTRUCTION CASE USING VIALITY AND HE COULD NOT GET SUCTION TO WORK TO THE STRENGTH HE NEEDED IT. THEY TRIED TO PUSH DOWN THE ACCESS CAP AND STILL WERE TOLD NOTHING WAS HELPING. CUSTOMER ENDED UP USING ANOTHER UNIT AND EVERYTHING WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2055863 VIALITY¿ LIPOASPIRATE WASH SYSTEM FAT TRANSFER QKL SIENTRA INC VIALITY-1400 00810076894621

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Unknown