BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVEVE SYSTEM

    MDR report key: 12001525 · Received June 15, 2021

    Report

    Report Number
    3013565579-2021-00001
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    May 18, 2021
    Report Date
    June 15, 2021
    Manufacturer
    VIVEVE, INC.
    Product Code
    GEI
    UDI-DI
    00850794007132
    PMA / PMN Number
    K162547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. SUSPECT PRODUCT INFORMATION IS NOT APPLICABLE TO THIS REPORT. THE CONSOLE, HANDPIECE AND TIPS INVOLVED IN THIS INCIDENT HAS BEEN RECEIVED FOR INVESTIGATION. TEST RESULTS HAVE LIKELY RULED OUT THE CONSOLE AS THE CAUSE. ADDITIONAL TESTING ON THE HANDPIECE AND TIPS SHOWED THAT THERE WAS A POSSIBILITY THAT THE CRYOGEN RETURN LUMEN HAS BEEN KINKED CLOSED WHEN IT WAS ATTACHED. VIVEVE RECREATED THE SCENARIO AND WAS ABLE TO RECREATE THE DELAMINATION, IDENTIFYING THE KINKED HANDPIECE LUMEN AS THE LIKELY CAUSE. THE BUILT-UP PRESSURE OF CRYOGEN FROM THE KINKED CAUSED THE TIP ELECTRODE TO SEPARATE FROM THE TIP. NO FAILURE OF THE TIP WOULD OCCUR UNDER NORMAL OPERATION OF THE HANDPIECE. IF RELEVANT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VIVEVE ON 18-MAY-2021 THAT A TREATMENT TIP DELAMINATED DURING A TREATMENT CAUSING AN ABRASION IN THE VAGINAL CANAL. PATIENT (PT) ORIGINALLY HAD A TREATMENT SCHEDULED FOR (B)(6) 2021 BUT TREATMENT WAS RESCHEDULED FOR (B)(6) 2021. PT RETURNED FOR THEIR RESCHEDULED TREATMENT ((B)(6) 2021) AND A NEW HANDPIECE (HP) WAS USED. THREE TIPS WERE USED DURING THIS TREATMENT, AND IT IS UNCLEAR FROM THE SITE WHICH OF THE THREE TIPS DELAMINATED. DURING USE OF ALL THREE TIPS THE PROVIDER FELT A FORCE FROM THE HP TOWARD THE PROVIDER. THE PROVIDER ALSO REPORTED AN ERROR APPEARED SAYING THE SYSTEM STOPPED DELIVERING RF/CRYOGEN. THE PT OPTED TO CONTINUE TREATMENT AFTER THIS OCCURRED WITH THE FIRST AND SECOND TIP. UPON EXAMINATION OF THE THIRD TIP, THE PROVIDER NOTICED A SMALL AMOUNT OF BLOOD. THE PROVIDER EXAMINED THE PT AND REPORTED AN ABRASION IN THE VAGINAL CANAL. THE PT WAS SENT HOME TO REST AND THE CLINIC PLANNED FOLLOW-UP WITH THE PT. THE NEXT DAY ((B)(6) 2021) THE PT REPORTED THAT THE DAY OF TREATMENT THEY HAD TO WEAR A TAMPON FOR BLEEDING AND NOW THEY WERE USING A PANTY LINER WITH LITTLE BLEEDING AND NO PAIN. ON (B)(6) 2021 THE PT CAME IN FOR A FOLLOW-UP. THE PT WAS DOING WELL AND THE ABRASION WAS HEALING WITHOUT ISSUES. ON (B)(6) 2021 THE CLINIC REPORTED THAT THE ABRASION WAS COMPLETELY HEALED, AND THE PT DID NOT REPORT ADDITIONAL PROBLEMS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898098 VIVEVE SYSTEM ELECTROSURGICAL SYSTEM GEI VIVEVE, INC. 88003S 00850794007132

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention