BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO TELESCOPE "ENDOEYE", 5 MM, 30°, PAL, AUTOCLAVABLE

    MDR report key: 21918398 · Received April 28, 2025

    Report

    Report Number
    9610773-2025-02989
    Event Type
    Malfunction
    Date Received
    April 28, 2025
    Report Date
    June 18, 2025
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: FACILITY NAME SHORTENED FROM "(GFO (B)(6). DUE TO RESTRICTION ON CHARACTERS ALLOWED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. 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: LIGHT GUIDE BUNDLE OF THE VIDEO CABLE SECTION WAS BROKEN, AND THE LIGHT TRANSMISSION WAS LOST OR TOO LOW. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: THE LIGHT GUIDE BUNDLE OF THE VIDEO CABLE SECTION WAS BROKEN AND THEREFORE THE LIGHT TRANSMISSION WAS LOST OR TOO LOW. IN REGARD TO THE NEWLY IDENTIFIED MALFUNCTION, THE CAUSE 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 REPORTED THE SUBJECT DEVICE PRESENTED AN IMAGE TOO DARK. THE ISSUE OCCURRED DURING INSPECTION FOR USE (SET UP IN ROOM / BEFORE PATIENT IN ROOM). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1596863 VIDEO TELESCOPE "ENDOEYE", 5 MM, 30°, PAL, AUTOCLAVABLE LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET OLYMPUS WINTER & IBE GMBH WA50022B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown