BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 0°, AUTOCLAVABLE

    MDR report key: 24767450 · Received April 2, 2026

    Report

    Report Number
    9610773-2026-02661
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    January 27, 2026
    Report Date
    April 2, 2026
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761074964
    PMA / PMN Number
    K190744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823705 VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 0°, AUTOCLAVABLE RIGID VIDEO LAPAROSCOPE HET OLYMPUS WINTER & IBE GMBH WA50040A 04042761074964

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown