BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 966524 · Received July 14, 2006

    Report

    Report Number
    2020550-2006-00041
    Event Type
    Other
    Date Received
    July 14, 2006
    Date of Event
    June 14, 2006
    Report Date
    July 14, 2006
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    FFK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DR WAS STARTING A BLADDER STONE REMOVAL USING ELECTOHYDRAULIC LITHOTRIPTOR AND WHEN POWER WAS ENGAGED TIP OF PROBE CAME OFF IN PT. DR RETRIEVED THE PIECE IMMEDIATELY; HE REPLACED PROBE AND THEN COMPLETED PROCEDURE. THERE WAS NO ADVERSE EFFECT ON PT; PT CONDITION POST-OP WAS STABLE. PROBE WAS NOT RETURNED FOR EVAL; IT WAS DISCARDED BY HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ LITHOTRIPSY PROBE FFK KARL STORZ GMBH & CO. KG 27080FA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other