BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 0°, AUTOCLAVABLE

    MDR report key: 17088695 · Received June 8, 2023

    Report

    Report Number
    9610773-2023-01587
    Event Type
    Malfunction
    Date Received
    June 8, 2023
    Report Date
    July 27, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761074964
    PMA / PMN Number
    K111788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND REPAIR. DURING THE EVALUATION, THE REPORTED ISSUE WAS CONFIRMED. THE R-UNIT IS BROKEN AND THEREFORE THE IMAGE WAS PURPLE. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, THE ROOT CAUSE OF THE REPORTED DEFECT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. IN GENERAL, THE CUSTOMER IS REQUIRED TO INSPECT THE DEVICE FOR DEFECTS, CHECK THE FUNCTION OF ALL DEVICES AND HAVE ALTERNATE EQUIPMENT PRIOR TO USE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE. ADDITIONAL PMA/510(K): K190744

    Additional Manufacturer Narrative · 0

    CORRECTION TO G2, ADDING OTHER AND UNITED KINGDOM. INFORMATION WAS INADVERTENTLY NOT INCLUDED ON THE INITIAL MEDWATCH. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 4 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY IMAGE ISSUE OCCURRED DUE TO A DEFECTIVE R-UNIT (CHARGE-COUPLED DEVICE). HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT A VIDEOTELESCOPE HAD INTERFERENCE LINES ON THE IMAGE POST PROCEDURE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS IDENTIFIED: THE R-UNIT IS BROKEN AND THEREFORE THE IMAGE WAS PURPLE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267098 VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 0°, AUTOCLAVABLE RIGID VIDEO SCOPE HET OLYMPUS WINTER & IBE GMBH WA50040A 04042761074964

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown