BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23769425 · Received December 10, 2025

    Report

    Report Number
    9610773-2025-08103
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    November 13, 2025
    Report Date
    December 10, 2025
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761074971
    PMA / PMN Number
    K190744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE FOREIGN MATERIAL IN THE LLK PLUG OF THE VIDEO CABLE SECTION WAS NOT ESTABLISHED. THE MOST PROBABLE CAUSE OF THE FIBER BONDING IN THE OUTER TUBE AREA (DISTAL END) DAMAGE WAS TRACED TO COMPONENT FAILURE. 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 OBSERVED THAT DURING THE DEVICE EVALUATION, THE LAPAROSCOPE EXHIBITED FIBER BONDING IN THE OUTER TUBE AREA (DISTAL END) WAS DAMAGED AND LIGHT LASER CABLE (LLK) PLUG OF THE VIDEO CABLE SECTION CONTAINS FOREIGN MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2107353 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