BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOPKINS TELESCOPE 30°, 4 MM, 30 CM

    MDR report key: 22136077 · Received June 3, 2025

    Report

    Report Number
    9610617-2025-00975
    Event Type
    Malfunction
    Date Received
    June 3, 2025
    Date of Event
    May 13, 2025
    Report Date
    October 20, 2025
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FAJ
    UDI-DI
    04048551001066
    PMA / PMN Number
    K943176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL BE FORWARDED TO THE MANUFACTURING SITE FOR 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

    CORRECTION HAS BEEN MADE IN SECTION H6, HEALTH EFFECT - IMPACT CODE (F): 2199. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Additional Manufacturer Narrative · 0

    CONCLUSION: THE CUSTOMER'S SPECIFICATIONS CAN BE CONFIRMED. THE IMAGING OF THE OPTICS IS MILKY AND CLOUDY AND SHOWS SLIGHT BLURRING ACROSS THE ENTIRE IMAGE. THE SYSTEM SHAFT IS BENT IN THE PROXIMAL DIRECTION, WHICH EXPLAINS THE SPALLING OF INDIVIDUAL ROD LENSES. FURTHERMORE, WHEN FOCUSING THROUGH THE INDIVIDUAL ROD LENSES, SEVERE ABRASION IS VISIBLE IN THE ROD LENS SYSTEM. THE EXTREMELY PRONOUNCED AND EVENLY DISTRIBUTED ABRASION INDICATES THAT THE LENS HAS BEEN CLEANED USING ULTRASOUND, WHICH MUST NOT BE DONE UNDER ANY CIRCUMSTANCES WITH THIS LENS OR ANY OTHER LENS BASED ON ROD LENSES. IN LINE WITH ITS USE, THERE ARE SCRATCHES AND IMPACT MARKS ON THE LENS AND SLIGHT CORROSION IN THE PRODUCT MARKING. THE DEFECTS IDENTIFIED DURING THE ROOT CAUSE ANALYSIS CANNOT BE ATTRIBUTED TO A MANUFACTURING/PRODUCTION ERROR. LIKELY, THE DAMAGE WAS CAUSED BY INCORRECT CLINICAL PROCESSING OR BY CLINICAL USE AND MECHANICAL OVERLOAD IN THE SHAFT AREA. NO FURTHER MEASURES WILL BE TAKEN. THE ABOVE CONDUCTED INVESTIGATIONS 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 DEVICES MANUFACTURING RECORDS. THE LABELLING WAS FOUND TO CONTAIN ADEQUATE INSTRUCTIONS AND WARNINGS. THE COMPLAINT HISTORY DID NOT REVEAL ANY PICK UP IN SIMILAR COMPLAINTS, NO TREND WAS IDENTIFIED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED IN THE EVENT DESCRIPTION SCOPE WAS BLURRY. NO HARM OR INJURY TO PATIENT REPORTED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066148 HOPKINS TELESCOPE 30°, 4 MM, 30 CM HOPKINS TELESCOPE 30°, 4 MM, 30 CM FAJ KARL STORZ SE & CO. KG R27005BA 04048551001066

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown