BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 2281699 · Received October 3, 2011

    Report

    Report Number
    MW5022522
    Event Type
    Other
    Date Received
    October 3, 2011
    Date of Event
    September 19, 2011
    Report Date
    October 3, 2011
    Manufacturer
    KARL STORZ GMBH & CO
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UNDERWENT ATTEMPTED REMOVAL OF BLADDER STONE ("GOLF BALL SIZE") USING 100 WT HOMIUM LASER. AFTER 'ABOUT TWO HOURS" OF LASER TIME, THE LITHOTRITE STONE CRUSHING FORCEPS WERE USED TO BREAK THE STONE INTO SMALLER FRAGMENTS. ONE OF THE JAW TIPS BROKE OFF. THE PT IS SCHEDULED TO UNDERGO AN OPEN PROCEDURE TO REMOVE THE REAMING STONE PIECES AND THE RETAINED JAW; A T.U.R. WAS ALSO PLANNED, BUT THE PROSTATE WILL BE RE-SECTED DURING THE UPCOMING OPEN PROCEDURE AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ STONE CRUSHING FORCEPS FFL KARL STORZ GMBH & CO 27074 B DM 01

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other