BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ LITHOTRIPSY

    MDR report key: 2804267 · Received July 14, 2006

    Report

    Report Number
    9613347-2006-00037
    Event Type
    Other
    Date Received
    July 14, 2006
    Date of Event
    June 8, 2006
    Report Date
    July 5, 2006
    Manufacturer
    STORZ MEDICAL
    Product Code
    FFK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR SERVICE TECH COULD NOT DUPLICATE THE PROBLEM AND DECIDED TO REPLACE THE BASIC MOTION CONTROL BOARD TO ELIMINATE THE POSSIBLE SOURCE OF THE PROBLEM. THE CONTROL PANEL CONNECTION HAD INDICATION OF ARCING WHICH COULD BE CAUSED FROM THE OPERATOR PLUGGING OR UNPLUGGING THE CONNECTION INTO THE TABLE WHILE THE TABLE IS POWERED UP. THE OPERATOR WAS CAUTIONED AGAINST THIS PRACTICE. THE CONTROL PANEL IS REPLACED AS WELL.

    Description of Event or Problem · 1

    PT WAS SCHEDULED FOR AN ESWL PROCEDURE. ALTHOUGH THE SLX-F2 UNIT WORKED EARLIER WITH THE 1ST PT, THE TABLE WAS LOCKED AND CAN'T BE UNLOCKED OR MOVED ANYMORE. THE DECISION WAS MADE TO CONVERT THE ESWL PROCEDURE TO A LASER LITHOTRIPSY. WITHIN ABOUT 45 MINUTES DELAY, PT WAS MOVED FROM THE LITHO TABLE TO CYSTO TABLE AND FROM CONSCIOUS SEDATION TO GENERAL IV ANESTHESIA WHERE A CONSENT FORM WAS ALSO SIGNED BY THE FAMILY. PROCEDURE WAS COMPLETED WITH NO PROBLEM AND PT POST-OP CONDITION WAS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ LITHOTRIPSY ESWL FFK STORZ MEDICAL SLX-F2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other