BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 564067 · Received January 5, 2005

    Report

    Report Number
    2020550-2004-00024
    Event Type
    Other
    Date Received
    January 5, 2005
    Date of Event
    November 19, 2004
    Report Date
    December 23, 2004
    Manufacturer
    KARL STORZ IMAGING, INC.
    Product Code
    FWF
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A URETEROSCOPY PROCEDURE DOCTOR COMPLAINED THAT THE IMAGE WAS CUT OFF AT THE BOTTOM OF THE SCREEN AND IT WAS ALL RED. WHILE PASSING A CATHETER THROUGH, THERE WAS EXCESSIVE BLEEDING AND DOCTOR SUSPECTED THE PT'S PROSTATE MIGHT HAVE BEEN NIPPED A LITTLE. THE PROCEDURE WAS COMPLETED AND PT WAS HOSPITALIZED OVERNIGHT AND HAD TURP THE NEXT DAY. POST-OP PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ CAMERA FWF KARL STORZ IMAGING, INC. 22220132-3 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other