BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM MICROVASCULAR ANASTOMOTIC COUPLER

    MDR report key: 3162494 · Received June 6, 2013

    Report

    Report Number
    2183620-2013-00008
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    April 17, 2013
    Report Date
    May 7, 2013
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    MVR
    PMA / PMN Number
    K861985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE DEVICE HISTORY RECORD, THE DEVICES MET SPECIFICATION PRIOR TO MARKET RELEASE. A 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. NO FUNCTIONAL TESTING WAS PERFORMED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    DURING A SURGICAL COUPLING PROCEDURE, THE TWO RINGS OF THE GEM MICROVASCULAR ANASTOMOTIC COUPLER DID NOT APPROXIMATE CORRECTLY DUE TO A MISALIGNMENT OF THE COUPLER PINS. THE SURGEON OBSERVED THE MISALIGNMENT AND ELECTED TO NOT USE COUPLER DEVICE. ANOTHER GEM MICROVASCULAR ANASTOMOTIC COUPLER WAS USED TO COMPLETE THE ANASTOMOSIS. THE SURGERY WAS COMPLETED WITHOUT INCIDENT AND WITHOUT ANY ADVERSE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251216 GEM MICROVASCULAR ANASTOMOTIC COUPLER ANASTOMOTIC COUPLER MVR SYNOVIS SURGICAL INNOVATIONS GEM2752 5791610-1699633

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK