BEUDAMED
    FDA Adverse Event Other Summary report: N

    LITHOTRITE

    MDR report key: 32982 · Received April 26, 1996

    Report

    Report Number
    2020550-1996-00006
    Event Type
    Other
    Date Received
    April 26, 1996
    Date of Event
    March 21, 1996
    Report Date
    April 16, 1996
    Manufacturer
    KARL STORZ GMBH & CO.
    Product Code
    FGK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS SCHEDULED FOR TURP AND BLADDER STONE REMOVAL. DUE TO THE SIZE OF THE PROSTRATE, SUPRAPUBIC PROSTATECTOMY WAS PLANNED. THE JAWS OF THE DEVICE BECAME MISALIGNED WHILE IN USE. SURGEON WAS UNABLE TO REALIGN IT AND PROCEDURE WAS CONVERTED TO OPEN SURGERY IMMEDIATELY. PT IS RECOVERING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 * Other