BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16574239 · Received March 20, 2023

    Report

    Report Number
    9610773-2023-00811
    Event Type
    Malfunction
    Date Received
    March 20, 2023
    Date of Event
    January 12, 2023
    Report Date
    April 20, 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
    CH
    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 THEIR INSPECTION, THE SBC DETECTED VARYING-COLORED IMAGES (PURPLE/GREEN). BY DISASSEMBLING THE DEVICE AND TESTING THE COMPONENTS INDIVIDUALLY, THE IMAGE ERROR COULD BE TRACED BACK TO THE R-UNIT. FURTHERMORE, THE SBC FOUND THE OUTER TUBE TO BE DENTED. 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

    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 PMA/510(K): K190744.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT ON (B)(6) 2023, A VIDEO TELESCOPE, DURING PREPARATION FOR USE, THE IMAGE WAS GREEN. THEN CHANGED TO ANOTHER DEVICE AND FINISHED THE PROCEDURE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1650312 VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE LAPAROSCOPE HET OLYMPUS WINTER & IBE GMBH WA50042A 04042761074971

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown