BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMMETRY VESOLOCK

    MDR report key: 7864584 · Received September 11, 2018

    Report

    Report Number
    3008007489-2018-00002
    Event Type
    Malfunction
    Date Received
    September 11, 2018
    Date of Event
    August 13, 2018
    Report Date
    September 11, 2018
    Manufacturer
    VESOCCLUDE MEDICAL LLC
    Product Code
    FZP
    PMA / PMN Number
    K152082
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QUALITY ASSURANCE INVESTIGATION IS COMPLETE WITH THE FOLLOWING RESULTS: UNFORTUNATELY, THE VESOLOCK CLIP/CARTRIDGE INVOLVED IN THE INCIDENT WAS NOT ABLE TO BE RETURNED. THE INCIDENT OCCURRED WHILE USING AN INTUITIVE ROBOTIC ENDOWRIST APPLIER. IT IS UNKNOWN THE APPLIER'S CONDITION AND HOW MANY TIMES IT HAD BEEN USED AS IT COULD NOT BE EVALUATED. IN MAY 2017, SYMMETRY SURGICAL PERFORMED VALIDATION TESTING FOR THE USE OF VESOLOCK POLYMER CLIPS (MED/LARGE AND LARGE) WITH THE TELEFLEX ROBOTIC HEMOLOCK APPLIERS (MED/LARGE AND LARGE). OUR VESOLOCK CLIPS WERE ALREADY VALIDATED WITH THE HEMOLOCK MANUAL APPLIER SO TESTING WAS REPEATED IN A ROBOTIC LAB SETTING FOR CLIP PICK UP, FIT, SECURITY, AND CLOSURE. RESULTS OF THIS TESTING DETERMINED THAT THE VESOLOCK CLIPS ARE COMPATIBLE WITH THE ROBOTIC ASSISTED CLIP APPLIERS. THE SAME CAUTIONS OUTLINED IN THE IFU FOR MANUAL APPLIERS APPLY FOR THE USE OF ROBOTIC ASSISTED APPLIERS. IT IS VERY IMPORTANT TO: VERIFY THE STRUCTURAL SIZE AND CONDITION OF THE VESSEL OR STRUCTURE PRIOR TO LIGATION AND USE THE PROPER CLIP SIZE. ENSURE CLIP IS PROPERLY POSITIONED/LOADED IN THE ROBOTIC ASSISTED HEMOLOCK APPLIER JAW. ALSO ENSURE THE CLIP DOES NOT BECOME RE-POSITIONED MANUALLY UPON INSERTION THROUGH THE CANNULA, WHICH COULD HAPPEN IF A CLIP WAS MISS-LOADED DURING PICK-UP. VISUALLY CONFIRM THAT THE CLIP IS SECURELY LATCHED TO ENSURE PROPER LIGATION OF THE VESSEL OR TISSUE.

    Description of Event or Problem · 1

    A VESOLOCK CLIP POPPED OFF A VESSEL WHILE THE SURGEON, DR. (B)(6) WAS PERFORMING A ROBOTIC WHIPPLE, CAUSING THE SURGEON TO CONVERT TO AN OPEN PROCEDURE BECAUSE HE WAS UNABLE TO CONTROL THE BLEEDING. DR. (B)(6) WAS USING A MEDIUM-LARGE ENDOWRIST CLIP APPLIER ON A DA VINCI ROBOT WHILE PLACING THE CLIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707129 SYMMETRY VESOLOCK CLIP, LIGATION FZP VESOCCLUDE MEDICAL LLC 51114V 7862

    Patients

    Seq Age Sex Outcome Treatment
    1