BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM MICROVASCULAR ANASTOMOTIC COUPLER

    MDR report key: 1577780 · Received January 7, 2010

    Report

    Report Number
    2183620-2010-00002
    Event Type
    Malfunction
    Date Received
    January 7, 2010
    Date of Event
    November 30, 2009
    Report Date
    December 9, 2009
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    MVR
    PMA / PMN Number
    K861985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT IMPLANTED. THE COUPLER DEVICE WAS NOT RETURNED FOR EVALUATION. 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 MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    SAME PROBLEM AND REPORTER AS THE FOLLOWING MANUFACTURING REPORT NUMBERS, BUT SEPARATE EVENTS: 2183620-2010-00003, 2183620-2010-00004. ON (B)96)2009, A PHYSICIAN WAS PERFORMING A VESSEL ANASTOMOTIC PROCEDURE USING A 3.0 MM COUPLER ON AN UNSPECIFIED BREAST. THE 3.0 MM COUPLER WAS UNABLE TO STAY IN THE WINGED JAW ASSEMBLY. THE PHYSICIAN REPORTED THAT THE COUPLER RING SLIPPED SLOWLY WHEN THE RINGS WERE GOING TO BE JOINED, ENOUGH SO THAT THE PINS NO LONGER FIT WITH THE HOLES. THIS OCCURRED WITH 2 SUBSEQUENT SETS OF 3.0 MM COUPLERS FROM THE SAME DISTRIBUTION BOX. THE PHYSICIAN PROCEEDED WITH THE ANASTOMOSIS BY USING A 2.5 MM COUPLER AND SUCCESSFULLY FINISHED THE ANASTOMOSIS. THE PROCEDURE WAS DELAYED BY APPROXIMATELY HALF AN HOUR. THE PATIENT'S STATUS IS REPORTED AS "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM MICROVASCULAR ANASTOMOTIC COUPLER ANASTOMOTIC COUPLER MVR SYNOVIS SURGICAL INNOVATIONS GEM2753 25476

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK