BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM MICROVASCULAR ANASTOMOTIC COUPLER

    MDR report key: 4110870 · Received September 16, 2014

    Report

    Report Number
    2183620-2014-00012
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 14, 2014
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    MVR
    PMA / PMN Number
    K861985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED. 100% FUNCTIONAL ALIGNMENT TESTING 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 TEST RESULTS WERE WITHIN SPECIFICATION. THE RELEASE PRODUCT MET SPECIFICATION. THE COUPLER RINGS WERE RETURNED FOR EVALUATION. THE JAW ASSEMBLY WAS NOT RETURNED. THERE WAS TISSUE ON THE PINS OF BOTH RINGS. THERE IS NO EVIDENCE THAT THE RINGS WERE BROUGHT TOGETHER. THERE ARE NO MARKS ON THE SURFACE ON EITHER RING FROM A MISALIGNED RING CLOSING AGAINST IT. THE HOLES IN EACH RING DO NOT SHOW ANY DISPLACEMENT OF MATERIAL IN THE INSIDE DIAMETER. THERE ARE NO BENT PINS ON EITHER RING. ALL 6 PINS ON BOTH RINGS LOOK SHARP. THERE IS NO IMMEDIATE EVIDENCE TO SUPPORT WHY THE RINGS WOULD NOT STAY TOGETHER. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. SYNOVIS HAS ELECTED TO SUBMIT MDRS RELATED TO COUPLER MALFUNCTIONS REGARDLESS IF THE EVENT WAS CONSIDERED LIKELY OR UNLIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON HAD EVERTED THE VEIN ONTO THE COUPLER RINGS AND WAS ATTEMPTING TO CONNECT THE RINGS, BUT THE COUPLER RINGS WOULD NOT STAY PROPERLY CONNECTED. THE PROCEDURE WAS A GLOSSECTOMY TRACHEOSTOMY, RADICAL NECK DISSECTION WITH FREE FOREARM FLAP. THE SURGEON REMOVED THE NON-FUNCTIONING COUPLER USED A DIFFERENT COUPLER TO COMPLETE THE ANASTOMOSIS. THE PATIENT IS WELL. THERE WAS NO PATIENT INJURY OR ADVERSE OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572172 GEM MICROVASCULAR ANASTOMOTIC COUPLER ANASTOMOTIC COUPLER MVR SYNOVIS SURGICAL INNOVATIONS GEM2754 SPMCA14-04D0079

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR