BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16440805 · Received February 24, 2023

    Report

    Report Number
    9610773-2023-00586
    Event Type
    Malfunction
    Date Received
    February 24, 2023
    Report Date
    April 28, 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
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND REPAIR. 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 K190744 PMA/510(K).

    Additional Manufacturer Narrative · 0

    THIS MEDWATCH IS BEING SUPPLEMENTED WITH ADDITIONAL INFORMATION OBTAINED AND THE MANUFACTURER'S FINAL INVESTIGATION RESULTS. DURING INSPECTION, THE SERVICE DEPARTMENT IDENTIFIED A PINK-COLORED IMAGE DUE TO A DEFECTIVE R-UNIT. A PIXEL SHIFT WAS CLEARLY IDENTIFIED, WHICH IS CAUSED BY A SLIGHT SHIFT OF THE CCD CHIP IN THE R-UNIT. FURTHERMORE, THE SERVICE DEPARTMENT STATED¿ SIGNS OF RUST FOUND IN THE DEVICE LIKELY CAUSED BY A PREVIOUS MOISTURE INGRESS THAT LED TO THE CCD SENSOR FAILURE¿. ADDITIONALLY, THE SERVICE DEPARTMENT IDENTIFIES A CUT IN THE GREY PROTECTIVE HOSE. POTENTIAL CAUSES: PIXEL SHIFT: THE CAUSE IS VERY LIKELY WEAR AND TEAR. CUT IN HOSE: THE CAUSE IS VERY LIKELY IMPROPER HANDLING BY THE USER. A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT A TELESCOPE WAS SENT IN FOR REPAIR FOR COLOR PROBLEM. THE REPORTABLE EVENT WAS FOUND DURING ESTIMATION OF THE DEVICE. THERE WAS NO INJURY OR HEALTH DAMAGE DUE TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1994181 VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 0°, AUTOCLAVABLE LAPAROSCOPE HET OLYMPUS WINTER & IBE GMBH WA50040A 04042761074964

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown