BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM MICROVASCULAR ANASTOMOTIC COUPLER

    MDR report key: 1994320 · Received January 14, 2011

    Report

    Report Number
    2183620-2011-00006
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Report Date
    December 15, 2010
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    MVR
    PMA / PMN Number
    K861985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS IMPLANTED BUT THE DATE OF IMPLANT WAS UNK. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. 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.

    Description of Event or Problem · 1

    ON AN UNK DATE, DURING AN UNSPECIFIED PROCEDURE, A PHYSICIAN IMPLANTED A COUPLER DEVICE. DUE TO MISALIGNMENT OF THE PINS, THE LUMEN OF THE VESSEL WAS NARROWED. THE DEVICE WAS LEFT IN PLACE. THE PHYSICIAN WAS UNCONCERNED BY THE NARROWING OF THE VESSEL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK