BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17447245 · Received August 2, 2023

    Report

    Report Number
    9610773-2023-02116
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Report Date
    August 5, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761074971
    PMA / PMN Number
    K111788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THE SUGGESTED PHENOMENON OF "GREEN IMAGE" WAS CONFIRMED, AND PRESUMED TO HAVE BEEN DUE TO THE FOLLOWING: 1. CABLE PINS OF ODU CONNECTOR [ODU BEING A COMPANY'S NAME] ARE TOO SMALL FOR SHIELD CABLES ¿ SHIELD CABLES ARE GROUPED OF UP TO FOUR SINGLE CABLES AND THIS SHIELD GROUP IS TOO BIG IN DIAMETER FOR THE PINS OF ODU CONNECTOR. SOLDERING JOINTS OF SHIELD GROUP MIGHT BE TOO WEAK TO WITHSTAND THE FORCES WITHIN CABLE. 2. SEALING COMPOUND WITHIN ODU CONNECTOR DOES NOT SEAL THE SOLDERING JOINTS AND BARE CABLE CONTACTS COMPLETELY AGAINST STEAM ¿ CORROSION ON THE SOLDERING JOINTS AND BARE CABLES CAN BE SEEN AFTER SEVERAL AUTOCLAVE CYCLES. 3. MANUFACTURING JIG (B)(4) NOT FULLY SUITABLE FOR SOLDERING PROCESS ¿ CABLES AND SOLDERING JOINTS ARE UNDER STRESS DURING MANUFACTURING PROCESS AND THIS CAN LEAD TO PREMATURE DAMAGES OF THE SOLDERING JOINTS. 4. SOLDERING PROCESS AT THE MANUFACTURER IS NOT UP TO DATE. NEW GUIDELINES FOR SOLDERING PROCESS ARE AVAILABLE ¿ THE NEW GUIDELINES IMPROVE SOLDERING STABILITY AND MANUFACTURABILITY OF ¿GOOD¿ SOLDERING JOINTS. THE REPORTED EVENT GREEN IMAGE (CAUSED BY CABLE UNIT): ACTIONS WERE INITIATED FOR THIS ERROR PATTERN. AS PART OF THIS CHANGE, THE MANUFACTURING PROCESS REGARDING THE SOLDERED JOINTS BETWEEN CABLE AND ODU PLUG WAS IMPROVED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO AN OLYMPUS REPAIR FACILITY, AND AN EVALUATION OF THE DEVICE WAS PERFORMED. DURING EVALUATION, THE CUSTOMERS¿ INITIAL REPORT OF GREEN IMAGE WAS CONFIRMED. THEY ALSO NOTED MULTIPLE DENTS ON THE OUTER TUBE AND A LOOSE LIGHT GUIDE ADAPTER. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED TO OLYMPUS THE IMAGE IS GREEN WHILE USING VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE. THE MALFUNCTION WAS FOUND AT PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337522 VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE ENDOEYE HD II HET OLYMPUS WINTER & IBE GMBH WA50042A 04042761074971

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown