BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO-OPTIK "ENDOEYE 3D", 30°

    MDR report key: 20063825 · Received August 26, 2024

    Report

    Report Number
    9610773-2024-32284
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    August 20, 2024
    Report Date
    February 3, 2025
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GCM
    PMA / PMN Number
    K193026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E2/E3: NO INFORMATION AVAILABLE FOR THE OCCUPATION OF THE INITIAL REPORTER OR WHETHER THEY ARE A HEALTHCARE PROFESSIONAL. 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 LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTABLE MALFUNCTION WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: COMPONENTS FAILURE OF R-UNIT (CHARGED COUPLED DEVICE). BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. 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 HAD IMAGE WITH WHITE SCRATCHES. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    THE ISSUE WAS FOUND DURING EQUIPMENT INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293079 VIDEO-OPTIK "ENDOEYE 3D", 30° RIGID VIDEO LAPAROSCOPE GCM OLYMPUS WINTER & IBE GMBH WA50082A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown