BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM MICROVASCULAR ANASTOMOTIC COUPLER

    MDR report key: 6776731 · Received August 9, 2017

    Report

    Report Number
    1416980-2017-06490
    Event Type
    Malfunction
    Date Received
    August 9, 2017
    Date of Event
    July 13, 2017
    Report Date
    September 6, 2017
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    MVR
    PMA / PMN Number
    K861985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. THE DEVICE HISTORY RECORD WAS OBTAINED AND REVIEWED FOR LOT # SP17C17-1220053. THE COUPLER RING SEPARATION FORCE RESULTS NOTED IN THE DHR FOR THIS LOT WERE WITHIN SPECIFICATION. THE COUPLER RING RETENTION FORCE TEST RESULTS WERE WITHIN SPECIFICATION. 100% FUNCTIONAL ALIGNMENT TESTING WAS PERFORMED ON EACH DEVICE DURING THE MANUFACTURING PROCESS. 100% VISUAL INSPECTION FOR BROKEN OR MISSING PARTS WAS PERFORMED. THE LOT PASSED VISUAL AND FUNCTIONAL INSPECTION. THE RELEASED PRODUCT MET SPECIFICATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE DHR REVIEW INDICATES THAT THE LOT MET SPECIFICATION. THERE IS NO IMMEDIATE EVIDENCE TO SUPPORT WHY THE COUPLER RING SLID OUT OF THE WING JAW ASSEMBLY DURING USE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A GEM MICROVASCULAR ANASTOMOTIC COUPLER, MODEL GEM2752, LOT NUMBER SP17C17-1220053, DID NOT ALIGN PROPERLY DURING SURGERY ANASTOMOSIS (VENOUS). THE COUPLER WAS EXCISED AND A NEW COUPLER WAS USED TO COMPLETE THE ANASTOMOSIS. THERE WAS NO REPORT OF PATIENT INJURY OR POST-OP MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560658 GEM MICROVASCULAR ANASTOMOTIC COUPLER COUPLER MVR SYNOVIS SURGICAL INNOVATIONS GEM2752 SP17C17-1220053

    Patients

    Seq Age Sex Outcome Treatment
    1