BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KARL STORZ ENDOSCOPY

    MDR report key: 691457 · Received March 1, 2006

    Report

    Report Number
    MW1038176
    Event Type
    Malfunction
    Date Received
    March 1, 2006
    Date of Event
    February 27, 2006
    Report Date
    March 1, 2006
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA INC.
    Product Code
    FFK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING LITHOTRIPSY, THE TIP OF THE PROBE CAME OFF. THE TIP WAS FLUSHED FROM THE PT. DR STATED THE TIP WAS NOT LOST IN THE BLADDER. NO ADVERSE EFFECTS NOTED BY THE DR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ ENDOSCOPY 7 FR ELECTROHYDRAULIC LITHOTRIPSY PROBE FFK KARL STORZ ENDOSCOPY-AMERICA INC. 27080 FA 28617

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR