BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 24416008 · Received February 23, 2026

    Report

    Report Number
    9610773-2026-01335
    Event Type
    Malfunction
    Date Received
    February 23, 2026
    Date of Event
    January 21, 2026
    Report Date
    February 23, 2026
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761074971
    PMA / PMN Number
    K190744
    Removal / Correction Number
    3011050570-10/24/2023-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS NOT CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: DAMAGED FIBER BONDING IN THE OUTER TUBE AREA (DISTAL END) AND PURPLE IMAGE. BASED ON THE RESULTS OF THE INVESTIGATION, FOR THE REPORTED MALFUNCTION OF THE PICTURE FLASHING ON AND OFF, THE CAUSE COULD NOT BE DETERMINED. FOR THE ADDITIONAL MALFUNCTIONS OF DAMAGED FIBER BONDING IN THE OUTER TUBE AREA (DISTAL END) AND A PURPLE IMAGE, THE CAUSE WAS TRACED TO BE 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 LAPAROSCOPE, GYNECOLOGIC, HAD ITS PICTURE FLASHING ON AND OFF. THE ISSUE WAS FOUND DURING A THERAPEUTIC LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE DURING SEDATION. THE PROCEDURE WAS COMPLETED USING AN OLYMPUS BACKUP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479238 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