BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYOMEN INSTRUMENT

    MDR report key: 22939386 · Received September 2, 2025

    Report

    Report Number
    9610617-2025-01523
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Report Date
    January 19, 2026
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    HET
    UDI-DI
    04048551099001
    PMA / PMN Number
    K945211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE MANUFACTURER'S TECHNICAL INSPECTION, THE ERROR DESCRIPTION PROVIDED BY THE CUSTOMER, "PIECE BROKE OFF AND IS MISSING", COULD BE CONFIRMED. THE SPIRAL AT THE DISTAL END HAS BROKEN OFF. THIS DAMAGE IS THE RESULT OF MECHANICAL OVERLOAD. BASED ON THE AGE OF THE ITEM (MANUFACTURING DATE: 2016-01-15) AND THE PRESUMED NUMBER OF USES, A MANUFACTURING DEFECT CAN BE RULED OUT. THE INVESTIGATION DID NOT REVEAL A ROOT CAUSE RELATED TO THE LABELLING, THE DEVICE, OR ITS HISTORY. ALL PRODUCTION-RELATED QUALITY CHECKS WERE PASSED, AND NO NON-CONFORMITIES WERE IDENTIFIED IN THE DEVICE'S MANUFACTURING RECORDS. THE LABELLING WAS FOUND TO CONTAIN ADEQUATE INSTRUCTIONS AND WARNINGS. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER. THIS INFORMATION IS REFLECTED IN SECTION D9. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED: THE END OF THE INSTRUMENT HAS BROKEN OFF AND IS MISSING. THE CUSTOMER WAS MADE AWARE BUT WAS UNABLE TO CONFIRM WHERE THIS COULD HAVE HAPPENED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. HOWEVER, DUE TO THE MISSING PART, THIS MALFUNCTION IS BEING REPORTED AS A PRECAUTIONARY MEASURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245374 MYOMEN INSTRUMENT MYOMEN INSTRUMENT HET KARL STORZ SE & CO. KG 26175B NT01 04048551099001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown