BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO TELESCOPE "ENDOEYE HD II", 5.4 MM, 30°, AUTOCLAVABLE

    MDR report key: 24674659 · Received March 24, 2026

    Report

    Report Number
    9610773-2026-02159
    Event Type
    Malfunction
    Date Received
    March 24, 2026
    Date of Event
    December 8, 2025
    Report Date
    March 24, 2026
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761075015
    PMA / PMN Number
    K111788
    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. BASED ON THE RESULTS OF THE INVESTIGATION, THE REPORTABLE EVENTS DEFORMED OUTER TUBE, THE CHARGED COUPLED DEVICE (R-UNIT) HAD A KINK WERE TRACED TO COMPONENT FAILURE. HOWEVER, A DEFINITIVE ROOT CAUSE FOR THE EVENT LASER LIGHT CABLE (LLK) PLUG OF THE VIDEO CABLE SECTION CONTAINED FOREIGN MATERIAL COULD NOT BE ESTABLISHED. 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 RIGID VIDEO LAPAROSCOPE SHOWED A DEFORMED OUTER TUBE, THE CHARGED COUPLED DEVICE (R-UNIT) HAD A KINK, PREVENTING DISASSEMBLY AND REASSEMBLY. ADDITIONALLY, THE LASER LIGHT CABLE (LLK) PLUG OF THE VIDEO CABLE SECTION CONTAINED FOREIGN MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737386 VIDEO TELESCOPE "ENDOEYE HD II", 5.4 MM, 30°, AUTOCLAVABLE RIGID VIDEO LAPAROSCOPE HET OLYMPUS WINTER & IBE GMBH WA50052A 04042761075015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown