BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16686426 · Received April 5, 2023

    Report

    Report Number
    9610773-2023-00973
    Event Type
    Malfunction
    Date Received
    April 5, 2023
    Date of Event
    March 12, 2023
    Report Date
    May 9, 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
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 DEFECT OCCURRED DUE TO ONE OF THE 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 AND/OR THE SOLDERING PROCESS USED AT THE TIME OF MANUFACTURING WAS OUT OF DATE.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.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPORTED PROBLEM WAS CONFIRMED, THE SUSPECT DEVICE WAS FOUND TO HAVE A PURPLE-COLORED IMAGE DEFECT WHICH WAS ISOLATED TO A DEFECTIVE VIDEO CABLE UNIT. THE INSPECTION ALSO NOTED NON-REPORTABLE DEFECTS SUCH AS CORROSION AT THE CABLE ASSEMBLY AND FOG-FREE ERROR (E104). THE REVIEW OF THE DEVICE HISTORY RECORDS FOR THE AFFECTED LOT OR SERIAL NUMBER 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.

    Description of Event or Problem · 0

    THE CUSTOMER ENDOEYE HIGH DEFINITION II, AUTO VIDEO TELESCOPE WAS RETURNED TO OLYMPUS FOR REPAIR FOR A REPORTED ¿BAD IMAGE¿ DURING INSPECTION BEFORE USE. THERE WAS NO DELAY, AND THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR SCOPE. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED TO OLYMPUS. UPON INSPECTING AND TESTING, OLYMPUS IDENTIFIED A PURPLE-COLORED IMAGE DEFECT DUE TO A DEFECTIVE VIDEO CABLE UNIT. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE COLORED IMAGE DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2284460 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