BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17000329 · Received May 25, 2023

    Report

    Report Number
    9610773-2023-01425
    Event Type
    Malfunction
    Date Received
    May 25, 2023
    Report Date
    June 19, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761074971
    PMA / PMN Number
    K190744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. 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 PURPLE/GREEN IMAGE WAS DUE TO 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 CUSTOMER¿S REPORTED ISSUE WAS CONFIRMED. A PURPLE/GREEN COLORED IMAGE WAS DETECTED. THE IMAGE PROBLEM WAS ISOLATED TO A DEFECTIVE CABLE UNIT. THE INSPECTION ALSO NOTED THE DISTAL END FIBERS BONDING IS DAMAGED. THE DEVICE HISTORY RECORDS FOR THE AFFECTED SERIAL NUMBER WAS REVIEWED WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUE. THE INVESTIGATION IS STILL IN PROGRESS; HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. IN GENERAL, THE END-USER IS REQUIRED TO INSPECT THE DEVICE FOR DEFECTS, CHECK THE FUNCTION OF ALL DEVICES AND HAVE ALTERNATE EQUIPMENT PRIOR TO USE. ADDITIONAL 510(K): K111788.

    Description of Event or Problem · 0

    THE CUSTOMER RETURNED THE ENDOEYE HIGH-DEFINITION II, AUTOCLAVABLE VIDEO TELESCOPE FOR AN UNSPECIFIED IMAGE PROBLEM. THE REPORTED PROBLEM WAS FOUND DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME EQUIPMENT BUT WITH DIFFICULTY OF VISION AND LENGTHENED PROCEDURAL TIME BY APPROXIMATELY 15 MINUTES, NO CLINICAL IMPACT TO THE PATIENT. THE DEVICE WAS INSPECTED PRIOR TO USE BUT NO ABNORMALITIES WERE OBSERVED. NO DEATH, INJURY OR HARM WAS REPORTED. DURING THE DEVICE EVALUATION, A COLORED IMAGE (PURPLE/GREEN) WAS IDENTIFIED DUE TO A DEFECTIVE CABLE UNIT. THIS REPORT WILL BE SUBMITTED TO CAPTURE THE COLORED IMAGE FOUND DURING EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478144 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