BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VYCOR VIEWSITE BRAIN ACCESS SYSTEM

    MDR report key: 2672888 · Received July 25, 2012

    Report

    Report Number
    3005880844-2012-00001
    Event Type
    Malfunction
    Date Received
    July 25, 2012
    Date of Event
    June 26, 2012
    Report Date
    July 24, 2012
    Manufacturer
    VYCOR MEDICAL INC
    Product Code
    GZT
    PMA / PMN Number
    K060973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT USED AND THERE WAS NO EVENT TO REPORT. PARTICULATE WAS DISCOVERED ON INSPECTION BY FOREIGN DISTRIBUTOR AND INVESTIGATIONAL ANALYSIS STARTED AND CAPA OPENED. DEVICE IS CONTRACT MANUFACTURED FOR VYCOR MEDICAL INC. BY (B)(4).

    Description of Event or Problem · 1

    PARTICULATE OF AN UNK ORIGIN HAS BEEN REPORTED TO VYCOR MEDICAL BY ONE DISTRIBUTOR. THE UNIT WAS NOT USED IN SURGERY. THEREFORE, THERE IS NO INJURY OR ADVERSE EVENT. MFR IS INVESTIGATING SOURCE AND COMPOSITION OF CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VYCOR VIEWSITE BRAIN ACCESS SYSTEM SELF RETAINING RETRACTOR GZT VYCOR MEDICAL INC TC171105 VM-84350

    Patients

    Seq Age Sex Outcome Treatment
    1