BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17043501 · Received June 1, 2023

    Report

    Report Number
    9610773-2023-01503
    Event Type
    Malfunction
    Date Received
    June 1, 2023
    Date of Event
    May 6, 2023
    Report Date
    July 18, 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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED FOR EVALUATION AND THE CUSTOMER¿S REPORTED ISSUE WAS CONFIRMED. WHEN CONNECTED TO THE TEST EQUIPMENT, THE SCOPE PRODUCES A GREEN COLORED BAR AT THE BOTTOM OF THE IMAGE. THE PROBLEM HAS BEEN ISOLATED TO A DEFECTIVE CHARGED COUPLED DEVICE INTEGRATED INSIDE THE OUTER TUBE OR A DEFECTIVE CONNECTING CABLE. THE INSPECTION ALSO NOTED INDENTATIONS AT THE DISTAL END OF THE RIGID OUTER TUBE AND A CUT ON THE OUTER SHEATH OF THE CABLE UNIT. THE CONTROL HANDLE HAS STAIN MARKS. THE DEVICE HAS NOT BEEN REPAIRED IN THE PAST YEAR. A REVIEW OF THE MANUFACTURING AND QUALITY RECORDS (DHR) FOR THE AFFECTED SERIAL NUMBER WAS REVIEWED WITHOUT DETECTING 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.

    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 IS LIKELY THAT THE EVENT OCCURRED DUE TO A DEFECTIVE ADHESIVE BOND OF THE CHARGED COUPLED DEVICE UNIT CHIP. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING PREPARATION FOR USE FOR A LAPAROSCOPIC CHOLECYSTECTOMY, A GREEN COLOR WAS FOUND ON THE LOWER EDGE OF THE IMAGE. THE USER COMPLETED THE INTENDED PROCEDURE WITH ANOTHER DEVICE. THE PROCEDURE WAS NOT DELAYED MORE THAN 15 MINUTES AND NO PATIENT INJURY OR IMPACT HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2293804 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 OLYMPUS: CV-190 VIDEO PROCESSOR.