BEUDAMED
    FDA Adverse Event Death Summary report: N

    KARL STORZ

    MDR report key: 221999 · Received April 26, 1999

    Report

    Report Number
    2020550-1999-00006
    Event Type
    Death
    Date Received
    April 26, 1999
    Date of Event
    April 6, 1999
    Report Date
    April 26, 1999
    Manufacturer
    KARL STORZ GMBH & CO.
    Product Code
    FED
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A TURP PROCEDURE, A WHITE OBJECT WAS NOTED AND DR MADE ATTEMPT TO IRRIGATE THE OBJECT FROM THE BLADDER. THE PROCEDURE CONTINUED. THE PT BECAME BRADYCARDIC AND TREATMENT WAS STARTED BY ANESTHESIA AND STAFF. DR NOTED ABDOMINAL DISTENSION. THE RESECTOSCOPE WAS REMOVED AND A DEFECTIVE END WAS NOTED BY THE SURGEON. HOSPITAL WILL RETURN DEVICE TO KARL STORZ ENDOSCOPY-AMERICA, INC. FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ RESECTO SHEATH FED KARL STORZ GMBH & CO. 27040XB KN01

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death