BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO-OPTIK "ENDOEYE 3D", 30°

    MDR report key: 19992540 · Received August 15, 2024

    Report

    Report Number
    9610773-2024-32161
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    August 8, 2024
    Report Date
    October 17, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GCM
    UDI-DI
    04042761083492
    PMA / PMN Number
    K193026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. UPDATED FIELDS: D8, D9, G3, H2, H3, H4, H6, H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED DUE TO A BROKEN VIDEO CABLE. A ROOT CAUSE FOR THE BROKEN VIDEO CABLE COULD NOT BE IDENTIFIED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: THE LIGHT GUIDE-BUNDLE OF THE INSERTION SECTION IS BROKEN, AND THE LIGHT TRANSMISSION IS NOT GIVEN OR TOO LOW. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RIGID VIDEOSCOPE HAD NO IMAGE AND AN E226 SCOPE COMMUNICATION ERROR MESSAGE WAS DISPLAYED. THE ISSUES OCCURRED WHEN PREPARING THE DEVICE FOR USE DURING A LAPAROSCOPIC PROCEDURE. THE OPERATION WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT THE RIGID VIDEOSCOPE HAD NO IMAGE. AND AN E226 SCOPE COMMUNICATION ERROR MESSAGE WAS DISPLAYED. THE ISSUES OCCURRED, WHEN PREPARING THE DEVICE FOR USE, DURING A LAPAROSCOPIC PROCEDURE. THE OPERATION WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176831 VIDEO-OPTIK "ENDOEYE 3D", 30° RIGID VIDEO LAPAROSCOPE GCM OLYMPUS WINTER & IBE GMBH WA50082A 04042761083492

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown