BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 0°, AUTOCLAVABLE

    MDR report key: 20850201 · Received December 4, 2024

    Report

    Report Number
    9610773-2024-33655
    Event Type
    Malfunction
    Date Received
    December 4, 2024
    Date of Event
    November 5, 2024
    Report Date
    December 4, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761074964
    PMA / PMN Number
    K190744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 MALFUNCTION WAS IDENTIFIED, DURING THE DEVICE EVALUATION: BROKEN R-UNIT (CHARGED COUPLED DEVICE), PURPLE IMAGE. AND THE FIBER BONDING IN THE OUTER TUBE AREA (DISTAL END) IS DAMAGED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY, THAT THE LIGHTING PROBLEM, WITH A PINK LIGHT AND PURPLE IMAGE OCCURRED, DUE TO A BROKEN R-UNIT. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED, FOR THE FIBER BONDING IN THE OUTER TUBE AREA (DISTAL END) IS DAMAGED. 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 SUBJECT DEVICE EXPERIENCED A LIGHTING PROBLEM. WITH A PINK LIGHT OCCURRING, DURING THE OPERATION OF AN UNSPECIFIED THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1942604 VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 0°, AUTOCLAVABLE RIGID VIDEO LAPAROSCOPE HET OLYMPUS WINTER & IBE GMBH WA50040A 04042761074964

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown