BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM MICROVASCULAR ANASTOMOTIC COUPLER

    MDR report key: 2579716 · Received May 10, 2012

    Report

    Report Number
    2183620-2012-00047
    Event Type
    Malfunction
    Date Received
    May 10, 2012
    Report Date
    April 10, 2012
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    MVR
    PMA / PMN Number
    K861985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COUPLER DEVICES INVOLVED IN THE INCIDENT WERE NOT RETURNED FOR EVAL, AND THEREFORE, FUNCTIONAL TESTING COULD NOT BE PERFORMED. ACCORDING TO THE DEVICE HISTORY RECORD, THE DEVICES MET SPECIFICATION PRIOR TO MARKET RELEASE. THE 100% FUNCTIONAL ALIGNMENT TESTING IS PERFORMED ON EACH DEVICE AND 100% VISUAL INSPECTION FOR BROKEN OR MISSING PARTS AND PIN ALIGNMENT IS PERFORMED ON EACH ASSEMBLY DURING THE MANUFACTURING PROCESS. SAME REPORTER AS THE FOLLOWING MANUFACTURER REPORT NUMBERS, BUT SEPARATE EVENTS: 2183620-2012-00047, 2183620-2012-00048, 2183620-2012-00049, 2183620-2012-00050.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PROBLEM WITH THE 2.5MM COUPLER DURING A FIBULA FREE FLAP. THE RING CAME APART. THE ANASTOMOSIS WAS SUTURED BY HAND. NO FURTHER DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM MICROVASCULAR ANASTOMOTIC COUPLER ANASTOMOTIC COUPLER MVR SYNOVIS SURGICAL INNOVATIONS GEM2753 5781650-1544689

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK