BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO TELESCOPE "ENDOEYE 3D", 10 MM, 0°

    MDR report key: 20137096 · Received September 4, 2024

    Report

    Report Number
    9610773-2024-32399
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    August 29, 2024
    Report Date
    September 4, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GCM
    UDI-DI
    04042761083485
    PMA / PMN Number
    K193026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: MINOR STAINS UNDER DISTAL COVER GLASS. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE COMPLAINT IS CAUSE TRACED TO COMPONENT FAILURE. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. 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 OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO SCOPE EXHIBITED MINOR STAINS UNDER DISTAL COVER GLASS. THERE WAS NO PATIENT INVOLVEMENT. THIS INQUIRY WAS REOPENED AND ESCALATED AS COMPLAINT ACCORDING TO THE AVAILABLE INFORMATION ON THE INQUIRY UNDER DATASWEEP NON-CONFORMANCE. (KARC/495710/01-AUG-2024).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899034 VIDEO TELESCOPE "ENDOEYE 3D", 10 MM, 0° RIGID VIDEO SCOPE GCM OLYMPUS WINTER & IBE GMBH WA50080A 04042761083485

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown