BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUNNELER 600MM RIGID

    MDR report key: 23679348 · Received December 1, 2025

    Report

    Report Number
    3004721439-2025-00352
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Date of Event
    October 30, 2025
    Report Date
    December 1, 2025
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    GYK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON OUR INVESTIGATION RESULTS, WE CAN DETERMINE A VISIBLE DAMAGE OF THE TUNNELLER HANDLE. THE CAUSE OF THE DAMAGE IS NOT KNOWN TO US AT THE TIME OF THE EXAMINATION BECAUSE OF LIMITED INFORMATION CONCERNING THE CIRCUMSTANCES WHY A DAMAGE LIKE THIS COULD OCCUR. WE CAN EXCLUDE A DEFECT AT THE TIME OF RELEASE. THE PRODUCT MET ALL SPECIFICATIONS OF THE FINAL INSPECTION WHEN RELEASED FROM CHRISTOPH MIETHKE GMBH & CO. KG.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A TUNNELLER (#FX003SU) WAS USED FOR AN IMPLANTATION. ACCORDING TO THE COMPLAINANT, THE HANDLE OF THE TUNNELLER WAS CRACKED DURING USE. NO PATIENT COMPLICATIONS OR DELAYS WERE REPORTED AS A RESULT OF THE DAMAGE. THE COMPLAINED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2136680 TUNNELER 600MM RIGID HYDROCEPHALUS MANAGEMENT GYK CHRISTOPH MIETHKE GMBH & CO KG FX003SU 20078736

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention