BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOPKINS TELESCOPE 0°, 5.5 MM, 50 CM

    MDR report key: 22777159 · Received August 11, 2025

    Report

    Report Number
    9610617-2025-01402
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    July 9, 2025
    Report Date
    January 21, 2026
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    GCJ
    UDI-DI
    04048551314661
    PMA / PMN Number
    K935279
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULT: THE SYSTEM TUBE (SHAFT) OF THE OPTICS IS BENT. CRACKS AND BROKEN ROD LENSES ARE VISIBLE IN THE ROD LENS SYSTEM. THE IMAGE IS BLURRED AND FOGGY DUE TO THE BROKEN ROD LENSES. THE DISTAL END IS CHEMICALLY DAMAGED BUT INTACT. RESIDUES ARE VISIBLE BEHIND THE DISTAL COVER GLASS, WHICH ARE ATTRIBUTABLE TO MECHANICAL OVERLOAD (OVER BENDING) OF THE SHAFT AND THE BROKEN ROD LENSES. THE DAMAGE FOUND CANNOT BE ATTRIBUTED TO A MANUFACTURING/PRODUCTION DEFECT. THE OPTICAL SHAFT WAS SUBJECTED TO MECHANICAL OVERLOAD (EXCESSIVE BENDING), WHICH RESULTED IN THE BREAKAGE OF ONE OR MORE ROD LENSES. THIS HAS A NEGATIVE IMPACT ON IMAGING. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR FURTHER INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR FURTHER INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMAGE IS BLURRED AND DARK. CANNOT ADEQUATELY SEE TISSUE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2109827 HOPKINS TELESCOPE 0°, 5.5 MM, 50 CM HOPKINS TELESCOPE 0°, 5.5 MM, 50 CM GCJ KARL STORZ SE & CO. KG R26048ASA 04048551314661

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown