BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE CELLFINA SYSTEM

    MDR report key: 7640073 · Received June 26, 2018

    Report

    Report Number
    3006560326-2018-00006
    Event Type
    Malfunction
    Date Received
    June 26, 2018
    Date of Event
    May 22, 2018
    Report Date
    May 29, 2018
    Manufacturer
    ULTHERA, INC., MERZ DEVICE INNOVATION CENTER
    Product Code
    OUP
    UDI-DI
    00840763100537
    PMA / PMN Number
    K161885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE BLADE CARTRIDGE WAS RETURNED AND EVALUATED. A VISUAL INSPECTION WAS PERFORMED USING 10X MAGNIFICATION UNDER A MICROSCOPE. A BREAK WAS OBSERVED JUST ABOVE THE BLADE-SHAFT WELD AND THE BLADE TIP WAS FOUND TO BE BENT THUS CONFIRMING THE ISSUE. THIS MAY BE INDICATIVE OF A COLLISION WITH A HARD SURFACE. HOWEVER, THIS CONDITION WAS UNABLE TO BE CONFIRMED WITHOUT THE RETURN OF THE DISPOSABLE KIT RING COMPONENT FOR INVESTIGATION SO THE ROOT CAUSE OF THE ISSUE IS UNKNOWN. A SEARCH OF THE LOT COMPLAINT HISTORY FOR THE DEVICE WAS PERFORMED AND NO OTHER COMPLAINTS FOR THIS REPORTED CONDITION WITH THIS LOT NUMBER WERE OBSERVED. AN EVALUATION OF THE LOT HISTORY REVIEW FOUND THERE HAVE BEEN NO DESIGN CHANGES ASSOCIATED WITH THE CELLFINA CK1 DISPOSABLE KIT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE, AND ALL TESTING REQUIREMENTS WERE PASSED PRIOR TO RELEASE. A REVIEW OF THE COMPLAINT TREND ANALYSIS FOR THE REPORTED ISSUE OF "BLADE BREAKS" FOUND THE TREND TO BE WITHIN ACCEPTABLE LEVELS AND WILL CONTINUE TO BE MONITORED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE AFFILIATE STATED ON (B)(6) 2018 THAT THEY ARE RETURNING THE DEVICE FOR INVESTIGATION. WHEN ADDITIONAL INFORMATION REGARDING THIS DEVICE BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH FORM WILL BE FILED.

    Description of Event or Problem · 1

    A (B)(6) AFFILIATE FROM (B)(6) RECEIVED A REPORT ON (B)(6) 2018 REGARDING A CELLFINA BLADE. IT WAS REPORTED THAT AFTER 25 RELEASES, THE BLADE BROKE. THE AFFILIATE STATED THAT THERE WERE NO DISADVANTAGES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479562 THE CELLFINA SYSTEM CELLFINA SYSTEM OUP ULTHERA, INC., MERZ DEVICE INNOVATION CENTER CK-1 46401250 00840763100537

    Patients

    Seq Age Sex Outcome Treatment
    1