BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM MICROVASCULAR ANASTOMOTIC COUPLER

    MDR report key: 2121771 · Received May 20, 2011

    Report

    Report Number
    2183620-2011-00036
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 20, 2011
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    MVR
    PMA / PMN Number
    K861985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COUPLER DEVICES INVOLVED IN THE INCIDENT WERE NOT RETURNED FOR EVAL. A STERILE RETAINED SAMPLE FROM THIS LOT WAS VISUALLY EXAMINED AND TESTED FOR RING RETENTION FORCE (RETENTION OF RINGS IN JAW). BOTH LEFT AND RIGHT RINGS WELL EXCEEDED THE MINIMUM RING RETENTION FORCE. THERE WAS NOTHING NONCONFORMING IN THE RETAINED SAMPLE. ACCORDING TO THE DEVICE HISTORY RECORD, THE DEVICES MET SPECIFICATION PRIOR TO MARKET RELEASE. ONE HUNDRED PERCENT 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 MFG PROCESS.

    Description of Event or Problem · 1

    SAME PROBLEM AND REPORTER AS THE FOLLOWING MFR REPORT NUMBERS, BUT SEPARATE EVENTS: 2183620-2011-00040, 00044 00041 00045, 00043. DURING A BREAST FLAP RECONSTRUCTION, UPON ATTEMPTING TO CLOSE THE COUPLER WING JAW ASSEMBLY WITH THE INSTRUMENT TURN KNOB, THE PHYSICIAN REPORTED THE COUPLER SLIPPED OUT OF THE JAW WITH VERY LITTLE TOUCH OR TENSION. THIS OCCURRED WITH TWO EACH OF 2.5, 3.0, AND 3.5MM COUPLERS (TOTAL: 6 DEVICES). THE VESSEL WAS REPORTED TO BE PROPERLY EVERTED OVER THE PINS AND THERE WAS SOME SLACK AVAILABLE IN THE VESSEL, INDICATING THE ANASTOMOSIS WAS NOT TIGHT. TWO DIFFERENT VESSELS WERE ATTEMPTED TO BE APPROXIMATED. PHYSICIAN KEPT MOVING PROXIMAL SINCE THE COUPLERS WERE FALLING OUT AND THE VESSEL DIAMETER INCREASED PROXIMALLY. FOLLOWING SIX UNSUCCESSFUL ATTEMPTS TO IMPLANT A COUPLER, THE PHYSICIAN COMPLETED THE ANASTOMOSIS BY HAND-SEWING. PT'S STATUS WAS REPORTED TO BE "FINE" FOLLOWING PROCEDURE. THREE DAYS POST-OP, THE FLAP WAS LOST. BECAUSE NO COUPLER WAS IMPLANTED, FLAP LOSS WAS NOT ATTRIBUTED TO A COUPLER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM MICROVASCULAR ANASTOMOTIC COUPLER ANASTOMOTIC COUPLER MVR SYNOVIS SURGICAL INNOVATIONS GEM2754 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK