BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 980105 · Received December 27, 2007

    Report

    Report Number
    2020550-2007-00035
    Event Type
    Other
    Date Received
    December 27, 2007
    Date of Event
    October 9, 2007
    Report Date
    December 27, 2007
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DR WAS PERFORMING A STONE FRAGMENTATION AND REMOVAL PROCEDURE WHEN THE JAWS BECAME MISALIGNED AND WOULD NOT CLOSE. HE REMOVED INSTRUMENT; DURING THIS REMOVAL, THE PT'S URETHRA WAS TORN SLIGHTLY. DR COMPLETED PROCEDURE WITH NO FURTHER IMPACT ON PT. NO FURTHER MEDICAL TREATMENT WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ LITHOTRITE FFL KARL STORZ GMBH & CO. KG 27076A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other