BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOPKINS TELESCOPE 30°, 2.9 MM, 30 CM

    MDR report key: 22031464 · Received May 15, 2025

    Report

    Report Number
    9610617-2025-00866
    Event Type
    Malfunction
    Date Received
    May 15, 2025
    Report Date
    March 5, 2026
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    HIH
    UDI-DI
    04048551093832
    PMA / PMN Number
    K943176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION MADE IN SECTION D2B. THE CORRECT CODE IS HIH. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    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

    THE CUSTOMER'S STATEMENT THAT "THE LENS IS CRACKED" CAN BE CONFIRMED. DURING EXAMINATION OF THE OPTICS, A SEVERE BEND IN THE OPTICAL SHAFT WAS DETECTED IN THE FIRST THIRD OF THE DISTAL SHAFT AREA. THE BEND CAUSED A BREAK IN THE ROD LENS, WHICH LED TO A LOSS OF IMAGING.THE MECHANICAL DAMAGE FOUND IS NOT ATTRIBUTABLE TO A MANUFACTURING/PRODUCTION DEFECT BUT WAS POSSIBLY CAUSED DURING CLINICAL USE/CLINICAL REPROCESSING. NO FURTHER ACTION 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 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 LENS IS CRACKED AND THE VISIBILITY HAS DIMINISHED DURING MEDICAL PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327464 HOPKINS TELESCOPE 30°, 2.9 MM, 30 CM HOPKINS TELESCOPE 30°, 2.9 MM, 30 CM HIH KARL STORZ SE & CO. KG R26120BA 04048551093832

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown