BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOPKINS TELESCOPE 0°, 5 MM, 29 CM

    MDR report key: 22036394 · Received May 16, 2025

    Report

    Report Number
    9610617-2025-00872
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Report Date
    December 19, 2025
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    GCJ
    UDI-DI
    04048551092088
    PMA / PMN Number
    K935279
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IN QUESTION WAS RETURNED TO MANUFACTURER. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION IN SECTION G4 CORRECT -510K WAS ADDED K935279. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS SENT TO THE KARL STORZ SERVICE DEPARTMENT FOR INSPECTION. DURING THE TECHNICAL INSPECTION, THE ERROR DESCRIPTION PROVIDED BY THE CUSTOMER, " THE SCOPE HAS BLURRY IMAGE ", COULD NOT BE CONFIRMED. THE EXAMINATION DID NOT REVEAL ANY NEGATIVE IMAGE IN RELATION TO THE CUSTOMER'S SPECIFICATIONS. THE IMAGE IS CLEAR AND SHARPLY DEFINED AND SHOWS VERY GOOD DEPTH OF FIELD. WHEN FOCUSING ON THE INDIVIDUAL ROD LENS SECTIONS, ISOLATED FOREIGN PARTICLES ARE VISIBLE IN THE BLURRED AREA OF THE OPTICS, BUT THESE HAVE NO NEGATIVE IMPACT ON THE IMAGING. FURTHERMORE, AN IMPACT MARK AT THE DISTAL END AND CHEMICAL DAMAGE TO THE DISTAL SOLDER SEAM CAN BE SEEN. THE FOREIGN PARTICLES DETECTED MAY HAVE BEEN INTRODUCED INTO THE SYSTEM DURING THE PRODUCTION OF THE OPTICS, BUT AS MENTIONED ABOVE, THEY HAVE NO NEGATIVE IMPACT ON IMAGING. THE CHEMICAL DAMAGE DETECTED AND THE MECHANICAL DAMAGE AT THE DISTAL END ARE ATTRIBUTABLE TO CLINICAL REPROCESSING OR CLINICAL USE. THE ABOVE 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 DEVICE'S MANUFACTURING RECORDS. THE LABELLING WAS FOUND TO CONTAIN ADEQUATE INSTRUCTIONS AND WARNINGS. THE COMPLAINT HISTORY DID NOT REVEAL ANY PICKUP IN SIMILAR COMPLAINTS; NO TREND WAS IDENTIFIED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THE SCOPE HAS BLURRY IMAGE. 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
    84076 HOPKINS TELESCOPE 0°, 5 MM, 29 CM HOPKINS TELESCOPE 0°, 5 MM, 29 CM GCJ KARL STORZ SE & CO. KG R26046AA 04048551092088

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown