BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16893089 · Received May 9, 2023

    Report

    Report Number
    9610773-2023-01253
    Event Type
    Malfunction
    Date Received
    May 9, 2023
    Report Date
    May 31, 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
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION ALSO NOTED THE PROTECTIVE COVER OF THE VIDEO CABLE IS CUT AND THE TIP AT THE DISTAL END OF THE RIGID INSERTION TUBE HAS A CONTOURED SHARPNESS. THE DEVICE HISTORY RECORDS FOR THE SERIAL NUMBER WAS REVIEWED WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUE. THE DEVICE WAS MANUFACTURED ACCORDING TO VALID INSTRUCTIONS AND MET ALL SPECIFICATIONS. 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 (H6/H10). BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED. THE EVENT OCCURRED DUE TO A DEFECTIVE CABLE UNIT, HOWEVER, THE EXACT CAUSE OF THE DEFECT COULD NOT BE SPECIFIED. IT LIKELY THE CABLE UNIT FAILURE OCCURRED DUE TO ONE OF THE FOLLOWING; THE CABLE PINS ON THE CONNECTOR ARE TOO SMALL FOR THE SHIELD CABLES (SHIELD CABLES ARE GROUPED OF UP TO FOUR SINGLE CABLES AND THIS SHIELD GROUP IS TOO BIG IN DIAMETER FOR THE PINS ON THE CONNECTOR), THE SHIELD GROUPS SOLDERING JOINTS ARE TOO WEAK TO WITHSTAND THE FORCES WITHIN THE CABLE, THE SEALING COMPOUND WITHIN THE CONNECTOR DOES NOT SEAL THE SOLDERING JOINTS AND BARE CONTACTS COMPLETELY AGAINST STEAM RESULTING IN CORROSION, THE CABLES/SOLDERING JOINTS WERE UNDER STRESS DURING THE MANUFACTURING PROCESS WHICH LEAD TO PREMATURE DAMAGE, AND/OR THE SOLDERING PROCESS USED AT THE TIME OF MANUFACTURING WAS OUT OF DATE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER ENDOEYE HIGH DEFINITION II, AUTOCLAVABLE VIDEO TELESCOPE WAS RETURNED FOR EVALUATION FOR A REPORTED ¿IMAGE HAS GREEN CAST¿ WHICH WAS FOUND DURING AN UNSPECIFIED EVENT. UPON INSPECTING AND TESTING, A COLORED IMAGE DEFECT (GREEN) WAS IDENTIFIED DUE TO A FAULTY VIDEO CABLE. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE COLORED IMAGE DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725558 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