BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    153301

    MDR report key: 23451546 · Received November 3, 2025

    Report

    Report Number
    9610617-2025-01979
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Report Date
    November 3, 2025
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    LRC
    UDI-DI
    04048551001363
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER. 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

    IT WAS REPORTED THAT "THE BODY IS DEFECTED." THE TECHNICAL INSPECTION REVEALED THAT PART OF THE INSTRUMENT HAD BROKEN OFF. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1558869 153301 153301 LRC KARL STORZ SE & CO. KG 153301 UL02 04048551001363

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown