BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

    MDR report key: 16882387 · Received May 5, 2023

    Report

    Report Number
    9610773-2023-01231
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    May 3, 2023
    Report Date
    June 16, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761074971
    PMA / PMN Number
    K111788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION, AS WELL AS CORRECTIONS TO B5 AND G2. THE INFORMATION IN B5 AND G2 WAS INADVERTENTLY OMITTED FROM THE INITIAL MEDWATCH REPORT. PLEASE SEE UPDATES TO B5, G2, H3, H4, H6 AND H10. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. ADDITIONALLY, THE REPAIR CENTER FOUND THERE WAS CRACKED COVER GLASS AT THE DISTAL END OF THE OUTER TUBE. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, IT¿S LIKELY THE IMAGE ERROR (GREEN IMAGE) WAS DUE TO A DEFECTIVE CHARGED COUPLED DEVICE UNIT AND A DEFECTIVE CABLE UNIT. THE FINAL ROOT CAUSE OF THIS EVENT WAS UNABLE TO BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND REPAIR. THE INVESTIGATION IS STILL IN PROGRES. 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.

    Description of Event or Problem · 0

    THE GREEN IMAGE OCCURRED DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OLYMPUS, THAT A VIDEO TELESCOPE, HAD A GREEN IMAGE DURING A PROCEDURE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2213166 VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE RIGID VIDEO SCOPE HET OLYMPUS WINTER & IBE GMBH WA50042A 04042761074971

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown