BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

    MDR report key: 24723802 · Received March 30, 2026

    Report

    Report Number
    9610773-2026-02441
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Report Date
    March 29, 2026
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761074971
    PMA / PMN Number
    K190744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3- DATE OF EVENT IS UNKNOWN. ADDITIONAL INFORMATION WILL BE PROVIDED ONCE AVAILABLE. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, CAUSE NOT ESTABLISHED FOR LLK (LASER LIGHT CABLE PLUG OF THE VIDEO CABLE SECTION CONTAINS FOREIGN MATERIAL, AND CAUSE COULD BE COMPONENT FAILURE FOR FIBER BONDING IN THE OUTER TUBE AREA (DISTAL END) IS DAMAGED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DEVICE EVALUATION THE LAPAROSCOPE, GYNECOLOGIC HAD DAMAGED FIBER BONDING IN THE OUTER TUBE AREA (DISTAL END), AND THE LLK (LASER LIGHT CABLE) PLUG OF THE VIDEO CABLE SECTION CONTAINED FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787434 VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE LAPAROSCOPE, GYNECOLOGIC HET OLYMPUS WINTER & IBE GMBH WA50042A 04042761074971

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown