BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM MICROVASCULAR ANASTOMOTIC COUPLER

    MDR report key: 3063660 · Received April 12, 2013

    Report

    Report Number
    2183620-2013-00006
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 13, 2013
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    MVR
    PMA / PMN Number
    K861985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    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 MFG PROCESS. TWO JOINED RINGS WERE RETURNED FOR ANALYSIS, AS WELL AS THE JAW ASSEMBLY. THE JAW ASSEMBLY WAS VISUALLY INSPECTED AND NO DEFECTS WERE NOTED. THE SPRING WAS IN PLACE AND THERE WERE NO BROKEN COMPONENTS. THE RAILS AND RING SURFACE DO NOT SHOW ANY DEFECTS. THE PINS LOOK STRAIGHT AND SHARP AND FREE OF DEFECTS. THE RAILS OF THE RING LOOK PARALLEL, BUT MISALIGNED AS IF ONE RING WAS SEATED IN THE JAW AND ONE RING WAS NOT WHEN THEY WERE BROUGHT TOGETHER. DEVICE INSPECTION SUPPORTS THE REPORT THAT THE RINGS WERE MISALIGNED. THE USER IS INSTRUCTED IN THE IFU TO INSPECT THE RINGS PRIOR TO BRINGING THE RINGS TOGETHER. NO FUNCTIONAL TESTING WAS PERFORMED. THE RINGS WERE RETURNED JOINED TOGETHER, MISALIGNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 2.3MM COUPLER DEVICE DID NOT APPROXIMATE PROPERLY. THE COUPLER DID NOT ALIGN CORRECTLY, IT CAME IN AT AN ANGLE INSTEAD. AS THE COUPLER WAS BEING CLOSED, THE PINS DID NOT ALIGN WITH THE CORRESPONDING HOLES IN THE MATING RING. THE COUPLER WAS REMOVED AND ANOTHER COUPLER WAS USED TO COMPLETE THE ANASTOMOSIS. THE SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WERE NO PT SYMPTOMS OR ADVERSE OUTCOMES RELATED TO THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159435 GEM MICROVASCULAR ANASTOMOTIC COUPLER ANASTOMOTIC COUPLER MVR SYNOVIS SURGICAL INNOVATIONS GEM2753 5802904-1848853

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK