BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R26046BA

    MDR report key: 21567498 · Received March 10, 2025

    Report

    Report Number
    9610617-2025-00415
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    January 21, 2025
    Report Date
    January 26, 2026
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    GCJ
    UDI-DI
    04048551092132
    PMA / PMN Number
    K935279
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION IS PROVIDED IN SECTION G2. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER ON 09/27/2024 FOR REPAIR. THIS INFORMATION IS REFLECTED IN SECTION D9. THE EVALUATION WILL NOT BE AVAILABLE THE DEVICE WAS DEEMED UNREPAIRABLE THEREFORE IT WAS SCRAPPED. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Additional Manufacturer Narrative · 0

    RESULT OF INVESTIGATION: THE IMAGING IS POOR. BROKEN ROD LENSES WERE DETECTED. THE DEVICE WAS SENT TO THE US KARL STORZ ASSESSMENT AND REPAIR DEPARTMENT FOR INSPECTION. PRODUCT WAS NOT RETURNED KST. DURING THE TECHNICAL INSPECTION, THE ERROR DESCRIPTION PROVIDED BY THE CUSTOMER, "BLURRY OR DEFECTIVE", COULD BE CONFIRMED. DURING THE EXAMINATION OF THE OPTICS BY OUR US COLLEAGUES, BROKEN ROD LENSES WERE DISCOVERED. A BREAKAGE OF THE ROD LENSES CAN BE CAUSED BY MECHANICAL OVERLOAD DURING CLINICAL USE OR DURING CLINICAL REPROCESSING. AT THE TIME OF PRODUCT TESTING BY TEST LOT ON JANUARY 22, 2024, NO DEVIATIONS COULD BE DETECTED. THE DAMAGE CANNOT BE ATTRIBUTED TO A MANUFACTURING/PRODUCTION DEFECT. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCOPES BLURRY OR DEFECTIVE. NO NEGATIVE IMPACT TO THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173788 R26046BA R26046BA GCJ KARL STORZ SE & CO. KG 122TH5 04048551092132

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown