BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KARL STORZ

    MDR report key: 479900 · Received August 21, 2003

    Report

    Report Number
    2020550-2003-00018
    Event Type
    Injury
    Date Received
    August 21, 2003
    Date of Event
    June 23, 2003
    Report Date
    August 21, 2003
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    FFK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER LITHOCAST WAS USED TO BREAK A 3CM STONE, KARL STORZ STONE FORCEPS WAS USED TO FRAGMENT 2 BIG PIECES MEASURING ABOUT 7-12MM. THE FORCEPS BROKE OFF WHEN WORKING ON FIRST STONE. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY AND THE STONE FRAGMENTS AS WELL AS THE BROKEN JAW WERE REMOVED. PT WAS DISCHARGED ON 2ND DAY FOLLOWING PROCEDURE AND WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ OPTICAL STONE CRUSHING FORCEPS FFK KARL STORZ GMBH & CO. KG 27074B EG

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention