BEUDAMED
    FDA Adverse Event Death Summary report: N

    COHERENT

    MDR report key: 643022 · Received October 17, 2005

    Report

    Report Number
    643022
    Event Type
    Death
    Date Received
    October 17, 2005
    Date of Event
    October 3, 2005
    Report Date
    October 17, 2005
    Manufacturer
    LUMENIS, INC
    Product Code
    LNK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IN THE OR FOR A URETEROSCOPY, REMOVAL OF A DOUBLE-J STENT AND LASER OF URETERAL STRICTURE. CYSTO PERFORMED AND STENT REMOVED, GUIDEWIRES PLACED. UNABLE TO ADVANCE ENDOPYELOTOMY STENT OR DILATE WITH URETERAL ACCESS SHEATH. AN INCISION WAS MADE WITH A HOLMIUM/ND LASER AND TAKEN DOWN UNDER DIRECT VISION TO DISTAL ASPECT. A FAIR AMOUNT OF BLOOD WAS NOTED. AFTER THE IRRIGATION PRESSURE WAS TURNED OFF, PULSATION WAS NOTED. CONTRAST WAS INJECTED WITH DIRECT VISUALIZATION OF THE COMMON ILIAC ARTERY. THE PATIENT WAS TAKEN TO THE OR FOR REPAIR OF COMMON ILIAC ARTERY AND NEPHRECTOMY. ST CHANGES NOTED ON EKG EN ROUTE TO ICU POST OP. THE PATIENT WAS TAKEN TO THE CATH LAB WHERE SHE EXPIRED. HOLMIUM/ND LASER REMOVED FROM SERVICE IMMEDIATELY AND QUARANTINED BY CLNICAL ENGINEERING DEPARTMENT UNTIL EVALUATION BY LUMENIS SERVICE REPRESENTATIVE ON 10.10.2005. PERFORMANCE EVALUATION PERFORMED AND NO MALFUNCTION IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COHERENT HOLMIUM/ND LASER LNK LUMENIS, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death