BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE CELLFINA SYSTEM

    MDR report key: 8511822 · Received April 12, 2019

    Report

    Report Number
    3006560326-2019-00002
    Event Type
    Malfunction
    Date Received
    April 12, 2019
    Date of Event
    March 12, 2019
    Report Date
    March 13, 2019
    Manufacturer
    ULTHERA, INC., MERZ DEVICE INNOVATION CENTER
    Product Code
    OUP
    PMA / PMN Number
    K161885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED BY THE PRACTICE FOR INVESTIGATION ON 03-JUN-2019. A VISUAL EXAMINATION OF THE RETURNED DISPOSABLE KIT CARTRIDGE ASSEMBLY CONFIRMED THE BLADE WAS BROKEN. BASED ON INFORMATION RECEIVED, THE ROOT CAUSE FOR THE BLADE BREAKING OFF THE SHAFT HAS BEEN ATTRIBUTED TO THE USER MANIPULATING THE BLADE WHILE ATTEMPTING TO STRAIGHTEN IT. THE INSTRUCTIONS FOR USE FOR THE CELLFINA SYSTEM STATE: "WARNING: VISUALLY INSPECT THE MICROBLADE ASSEMBLY PRIOR TO AND DURING USE. DISCARD THE MICROBLADE ASSEMBLY IMMEDIATELY IF THERE ARE ANY SIGNS OF DAMAGE; INCLUDING, BUT NOT LIMITED TO, BENT BLADES, DAMAGED BLADES, OR BENT BLADE SHAFTS. DO NOT ATTEMPT TO STRAIGHTEN EITHER THE BLADE OR THE BLADE SHAFT." A REVIEW OF THE LOT COMPLAINT HISTORY FOR THIS LOT OF DISPOSABLE KITS REVEALED THERE WERE NO OTHER COMPLAINTS RECEIVED FOR THIS CONDITION. A REVIEW OF THE COMPLAINT TREND ANALYSIS FOR THE REPORTED ISSUE OF "BLADE BREAKS" FOUND THE TRENDS 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 13-MAR-2019 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 MERZ AFFILIATE FROM (B)(6) RECEIVED A REPORT ON (B)(6) 2019 REGARDING A CELLFINA DISPOSABLE KIT BLADE. THE BLADE WAS REPORTED TO BE BENT AFTER 30% OF THE TREATMENT, AND THE DOCTOR STRAIGHTENED THE BLADE. THE BLADE BENT A SECOND TIME, AND WHEN THE DOCTOR STRAIGHTENED THE BLADE AGAIN, THE BLADE BROKE. THE AFFILIATE REPORTED THAT NO PATIENT WAS HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304159 THE CELLFINA SYSTEM CELLFINA SYSTEM OUP ULTHERA, INC., MERZ DEVICE INNOVATION CENTER CK-1 2018051495

    Patients

    Seq Age Sex Outcome Treatment
    1 Other