BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 24331862 · Received February 13, 2026

    Report

    Report Number
    9610773-2026-01030
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Date of Event
    January 17, 2026
    Report Date
    February 13, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: THE IMAGE WAS NOT DISPLAYED, THE FIBER BONDING IN THE OUTER TUBE AREA (DISTAL END) WAS DAMAGED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE AND LOSS OF IMAGE WAS TRACED TO A BROKEN VIDEO CABLE. ADDITIONALLY, THE PROBABLE CAUSE OF THE BROKEN FIBER BONDING IN THE DISTAL END OUTER TUBE AREA WAS ATTRIBUTED 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 REPORTED THAT THE GYNECOLOGIC LAPAROSCOPE HAD FLICKERING IMAGE. THE EVENT OCCURRED DURING LAPAROSCOPIC ASSISTED RIGHT HEMICOLECTOMY THERAPEUTIC PROCEDURE WHILE THE PATIENT WAS UNDER SEDATION AND DEVICE WAS INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395099 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