BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16382310 · Received February 15, 2023

    Report

    Report Number
    9610773-2023-00510
    Event Type
    Malfunction
    Date Received
    February 15, 2023
    Date of Event
    January 18, 2023
    Report Date
    March 30, 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
    LU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MEDWATCH IS BEING SUPPLEMENTED WITH ADDITIONAL INFORMATION OBTAINED AND THE MANUFACTURER'S FINAL INVESTIGATION RESULTS. DURING INSPECTION, OSTE IDENTIFIES A GREEN IMAGE AND TRACES IT BACK TO THE R-UNIT. POSSIBLE CAUSES: - UNACCEPTABLE TENSION IN THE AREA OF THE "CCD (CHARGED COUPLED DEVICE) W. HOLDER" ASSEMBLY DUE TO USE OF AN ADHESIVE WHICH IS NOT ADAPTED TO THE LOAD / TEMPERATURE COLLECTIVE AND TO AN INSUFFICIENTLY FORMED ADHESIVE LAYER "C-HOLDER TO BUMPER SLEEVE" - UNACCEPTABLE TENSION IN THE AREA OF THE "CCD W. HOLDER" ASSEMBLY DUE TO ASYMMETRICAL ALIGNMENT OF THE SPRING TO C-HOLDER BEFORE THE BUMPER SLEEVE IS JOINED - PRE-EXISTING DAMAGE TO THE "CCD W. HOLDER" ASSEMBLY DUE TO USING A SUBOPTIMAL ADHESIVE DEVICE¿ A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUES.

    Additional Manufacturer Narrative · 0

    ADDITIONAL PMA/510(K) NUMBER K190744. THE DEVICE WAS RETURNED TO OLYMPUS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT A VIDEO TELESCOPE HAD AN IMAGE COLOR ROSE. IT IS UNKNOWN WHEN THE REPORTED ISSUE WAS FOUND. THERE WAS NO INJURY OR HEALTH DAMAGE DUE TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1291153 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