BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KARL STORZ ENDOSCOPY

    MDR report key: 938056 · Received October 30, 2007

    Report

    Report Number
    3701140000-2007-0005
    Event Type
    Malfunction
    Date Received
    October 30, 2007
    Date of Event
    October 24, 2007
    Report Date
    October 29, 2007
    Manufacturer
    KARL STORZ ENDOSCOPY
    Product Code
    FGK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A HOLMIUM LASER LITHOTRIPSY OF A LARGE BLADDER STONE WAS ATTEMPTED ON PATIENT. A LARGE SIZE LITHOTRITE WAS INSERTED INTO BLADDER. WHILE TRYING TO TRAP THE STONE, THE TWO END PIECES OF THE LITHOTRITE WENT IN OPPOSITE DIRECTIONS. THE INSTRUMENT COULD NOT BE REMOVED. THE PATIENT WAS TAKEN TO SURGERY. THE BLADDER WAS OPENED AND THE INSTRUMENT AND STONE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ ENDOSCOPY LITHOTRITE FGK KARL STORZ ENDOSCOPY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR