BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO-OPTIK "ENDOEYE 3D", 30°

    MDR report key: 18434222 · Received January 3, 2024

    Report

    Report Number
    9610773-2024-00062
    Event Type
    Malfunction
    Date Received
    January 3, 2024
    Date of Event
    December 19, 2023
    Report Date
    October 8, 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
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AND EVALUATED, AND THE CUSTOMER¿S ALLEGATION OF DAMAGE TO THE CHARGED COUPLED DEVICE COVER GLASS WAS NOT CONFIRMED, SHADOWY IMAGE WAS CONFIRMED DUE TO SCRATCHES ON THE CHARGED COUPLED DEVICE COVER GLASS. ADDITIONALLY, IT WAS FOUND THAT THERE WAS A BURST OR BROKEN PLAN GLASS AT THE TUBE. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. SECTIONS H4 AND H6 WERE UPDATED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT THE VIDEO-OPTIK "ENDOEYE 3D", 30° HAD A SHADOW IN THE IMAGE AND DAMAGE ON THE CHARGED COUPLED DEVICE COVER GLASS. THE EVENT OCCURRED DURING PREPARATION FOR USE IN A THERAPEUTIC PROCEDURE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762637 VIDEO-OPTIK "ENDOEYE 3D", 30° VIDEO SYSTEM CENTER GCM OLYMPUS WINTER & IBE GMBH WA50082A 04042761083492

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown