BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVEVE 2.0 SYSTEM

    MDR report key: 9732757 · Received February 20, 2020

    Report

    Report Number
    3013565579-2020-00001
    Event Type
    Injury
    Date Received
    February 20, 2020
    Date of Event
    November 5, 2019
    Report Date
    January 23, 2020
    Manufacturer
    VIVEVE, INC.
    Product Code
    GEI
    PMA / PMN Number
    K162547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE VIVEVE 2.0 SYSTEM NOTED IN THIS MDR REQUIRES THE USE OF AN ELECTRICAL RETURN PAD, PACKAGED AS SINGLE USE, AND MANUFACTURED BY 3M, MODEL NUMBER 9160. ALTHOUGH THE VIVEVE SYSTEM WAS RETURNED, THE RETURN PAD AND TIP WERE NOT RETURNED, PREVENTING A THOROUGH INVESTIGATION OF THE COMPLAINT. THE SITE WAS UNSURE OF THE LOT NUMBER OF THE RETURN PAD USED FOR THIS TREATMENT. THE VIVEVE 2.0 SYSTEM WAS RETURNED, WAS EVALUATED AND WAS FOUND TO BE PERFORMING AS INTENDED. IN OUR OPINION, BASED ON EARLY DEVELOPMENT TESTING, THERE WAS INCOMPLETE CONTACT OF THE RETURN PAD, RESULTING IN ALL ENERGY BEING CONCENTRATED IN A SMALL AREA, CAUSING A BURN.

    Description of Event or Problem · 1

    PER THE CLINICIAN: PT CALLED IN STATING THAT SHE HAD A BURN ON HER THIGH DUE TO THE VIVEVE PROCEDURE. IT HAS BEEN PRESENT FOR A COUPLE OF DAYS. PT DID NOT MENTION ANY DISCOMFORT ON THE THIGH AREA DURING OR RIGHT AFTER THE TX. UNFORTUNATELY, WE DID NOT DETECT THE BURN BEFORE SENDING THE PATIENT HOME. WE DID RECOGNIZE SOME REDNESS AND A TYPICAL REACTION AFTER REMOVING THE PAD". THE BURN WAS CONFIRMED BY THE TREATING PHYSICIAN AND THE PATIENT WAS REFERRED TO A BURN CENTER FOR FURTHER EVALUATION. THE PATIENT WAS TREATED WITH AQUAPHOR AND IT WAS CONFIRMED THROUGH FOLLOW UP ON (B)(6) 2019 THE BURN HAD RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197841 VIVEVE 2.0 SYSTEM ELECTROSURGICAL SYSTEM GEI VIVEVE, INC. 1413466-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention