BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM FLOW COUPLER DEVICE AND SYSTEM

    MDR report key: 5137946 · Received October 8, 2015

    Report

    Report Number
    1416980-2015-38416
    Event Type
    Malfunction
    Date Received
    October 8, 2015
    Report Date
    October 8, 2015
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    MVR
    PMA / PMN Number
    K093310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    "IMPLANTABLE COOK-SWARTZ DOPPLER PROBE VERSUS SYNOVIS FLOW COUPLER FOR THE POSTOPERATIVE MONITORING OF FREE FLAP BREAST RECONSTRUCTION" JOURNAL OF PLASTIC, RECONSTRUCTIVE & AESTHETIC SURGERY, MARCH 2014, 67, 960-966. IN THIS RETROSPECTIVE STUDY, THE AUTHORS REVIEWED 111 CONSECUTIVE FREE FLAP BREAST RECONSTRUCTIONS WHICH WERE MONITORED POST-OPERATIVELY USING THE SYNOVIS GEM MICROVASCULAR ANASTOMOTIC FLOW-COUPLER OVER A THREE-YEAR PERIOD (JANUARY 2009 - JANUARY 2012). ADVERSE OUTCOMES TOTALED FIVE (5) CASES REQUIRING OR TAKEBACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668318 GEM FLOW COUPLER DEVICE AND SYSTEM DEVICE,ANASTOMOTIC,MICROVASCULAR MVR SYNOVIS SURGICAL INNOVATIONS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1