BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM MICROVASCULAR ANASTOMOTIC COUPLER

    MDR report key: 2854418 · Received November 29, 2012

    Report

    Report Number
    2183620-2012-00095
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 29, 2012
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    MVR
    PMA / PMN Number
    K861985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. 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. THE RING RETENTION FORCE OF THE WING JAW ASSEMBLY (WJA) MEETS SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE HOSPITAL NURSE TRIED TO LOAD THE COUPLER INTO THE ANASTOMOTIC INSTRUMENT, ONE COUPLER RING CAME OUT OF THE WING JAW ASSEMBLY (WJA). THE COUPLER DEVICE WAS DISCARDED AND A NEW COUPLER DEVICE FROM THE SAME LOT NUMBER WAS SUCCESSFULLY USED FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM MICROVASCULAR ANASTOMOTIC COUPLER ANASTOMOTIC COUPLER MVR SYNOVIS SURGICAL INNOVATIONS GEM2751 5791100-1692723

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK