BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER CERAMIC INSULATION TUBE

    MDR report key: 14084349 · Received April 12, 2022

    Report

    Report Number
    9610617-2022-00031
    Event Type
    Malfunction
    Date Received
    April 12, 2022
    Date of Event
    March 9, 2022
    Report Date
    November 16, 2022
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FBO
    UDI-DI
    04048551076569
    PMA / PMN Number
    K943668
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CERAMIC TIP FRACTURED/BROKE FROM THE SHEATH AT END OF PROCEDURE WHEN PULLING OUT INSTRUMENT. A MISSING PIECE IS STILL IN PATIENT. THE SHEATH IS OVER 8 YEARS OLD.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION REPORT FROM KST/MFR. WAS RECEIVED WHICH STATES: THE CONCLUSION AND ROOT CAUSE OF THE NON-RETURN PRODUCT: "THE MOST LIKELY CAUSE IS THE AGE ( 8 YEARS) OF THE ITEM AND THE HIGH" APPLICATION CYCLES. THIS PROBABLY CAUSED MICRO CRACKS ON THE CERAMIC BEAK, WHICH LED TO THE BREAKAGE OF THE BEAK DURING EXTRACTION.

    Description of Event or Problem · 0

    DURING A TURP, SURGEON COMPLETED THE SURGERY, AND REALIZED WHEN PULLING OUT THE INSTRUMENTS THAT A BROKEN PIECE OF CERAMIC CAME OUT. A MISSING PIECE IS STILL IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146278 INNER CERAMIC INSULATION TUBE RESECTOSCOPE SHEATH, INNER FIXED SHEATH FBO KARL STORZ SE & CO. KG 27040XB NV01 04048551076569

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other