BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO-OPTIK "ENDOEYE 3D", 30°

    MDR report key: 20095607 · Received August 29, 2024

    Report

    Report Number
    9610773-2024-32344
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    August 16, 2024
    Report Date
    October 23, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GCM
    PMA / PMN Number
    K193026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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, H2, H3, H4, H6, H11. 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: VIDEO CABLE BROKEN, R-UNIT (CHARGED COUPLED DEVICE) IS BROKEN, LIGHT GUIDE BUNDLE OF THE INSERTION SECTION IS BROKEN, AND LIGHT TRANSMISSION IS NOT GIVEN 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: VIDEO CABLE IS BROKEN AND THEREFORE THE IMAGE IS NOT DISPLAYED, R-UNIT IS BROKEN AND THEREFORE THE 3D IMAGE HAS DEFECTS OR IS NOT DISPLAYED, LIGHT GUIDE BUNDLE OF THE INSERTION SECTION IS BROKEN AND THEREFORE THE LIGHT TRANSMISSION IS NOT GIVEN OR TOO LOW. 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 DURING THE PROCEDURE, THE RIGID VIDEOSCOPE HAD NO PICTURE. THERE WAS A COMMUNICATION ERROR AND THE PINS ON THE VIDEO UNIT NEEDED CLEANING. THE ERROR WAS IDENTIFIED, AND AN ATTEMPT WAS MADE TO CLEAN THE PINS ON THE VIDEO CONNECTOR, BUT THIS DID NOT RESOLVE THE ISSUE. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT DURING THE PROCEDURE. THE RIGID VIDEOSCOPE HAD NO PICTURE. THERE WAS A COMMUNICATION ERROR. AND THE PINS ON THE VIDEO UNIT NEEDED CLEANING. THE ERROR WAS IDENTIFIED. AND AN ATTEMPT WAS MADE TO CLEAN THE PINS ON THE VIDEO CONNECTOR, BUT THIS DID NOT RESOLVE THE ISSUE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1794152 VIDEO-OPTIK "ENDOEYE 3D", 30° RIGID VIDEO LAPAROSCOPE GCM OLYMPUS WINTER & IBE GMBH WA50082A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown