BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 974952 · Received May 25, 2007

    Report

    Report Number
    2020550-2007-00014
    Event Type
    Other
    Date Received
    May 25, 2007
    Date of Event
    April 25, 2007
    Report Date
    May 25, 2007
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    EZO
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DR WAS PERFORMING A DIRECT VISUAL INTERNAL URETHROTOMY AND TUR ON A MALE, WHEN MIDWAY THROUGH THE PROCEDURE 2 CM OF THE COLD KNIFE BLADE PLUS SHAFT BROKE OFF IN PT. DR SEARCHED BUT COULD NOT FIND THE BROKEN PIECE DUE TO THE SITE BEING TOO BLOODY TO ATTAIN GOOD VISUAL; HE USED EXTENSIVE IRRIGATION TO TRY AND CLEAR THE FIELD, BUT COULD NOT FIND THE PIECE. AT THAT TIME, DR STOPPED PROCEDURE. PT WAS RESCHEDULED AND DR WAS SUCCESSFUL IN RETRIEVING THE BROKEN PIECE AND COMPLETING THE ORIGINAL PROCEDURE WITH NO PT IMPACT. PT CONDITION POST-OP WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ COLD KNIFE EZO KARL STORZ GMBH & CO. KG 27069K 32004

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other