BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 24506909 · Received March 4, 2026

    Report

    Report Number
    9610773-2026-01678
    Event Type
    Malfunction
    Date Received
    March 4, 2026
    Date of Event
    February 5, 2026
    Report Date
    March 4, 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
    NURSE
    Health Professional
    Yes

    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 FIBER BONDING IN THE OUTER TUBE AREA (DISTAL END) IS DAMAGED, ERROR 218 OCCURS AND THEREFORE NO IMAGE IS DISPLAYED, OUTER TUBE (THERMISTOR) IS BROKEN A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE OUTER TUBE (THERMISTOR) IS BROKEN, WHICH RESULTED IN ERROR 104 AND THE VIDEO CABLE IS BROKEN, WHICH RESULTED IN ERROR 218 AND THEREFORE NO IMAGE IS DISPLAYED; AND FOR THE FIBER BONDING IN THE OUTER TUBE AREA (DISTAL END) DAMAGED, THE MOST PROBABLE CAUSE TRACED DUE TO A 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 DISPLAYED AN ERROR E104. THE ISSUE OCCURRED DURING A LAPAROSCOPIC THERAPEUTIC PROCEDURE THAT WAS COMPLETED WITH A BACKUP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477602 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 OTV-S300