BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 0°, AUTOCLAVABLE

    MDR report key: 16585535 · Received March 21, 2023

    Report

    Report Number
    9610773-2023-00829
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Report Date
    May 5, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761074964
    PMA / PMN Number
    K111788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS AND THE CUSTOMER¿S REPORTED PURPLE ARTIFACTS ON THE IMAGE PROBLEM COULD NOT BE CONFIRMED OR REPRODUCED. DURING TESTING OF THE DEVICE, IT WAS IDENTIFIED AN ALTERNATION BETWEEN IMAGE WITH NOISE AND AN INTERMITTENT DISAPPEARANCE OF THE IMAGE FUNCTION, ALONG WITH ENDOSCOPE COMMUNICATION ERRORS, E216 AND B30. THE ERROR(S) PROBLEM WAS ISOLATED TO A DEFECTIVE VIDEO CABLE UNIT. THE INSPECTION ALSO OBSERVED THE PLAN GLASS AT THE DISTAL END OF THE RIGID INSERTION TUBE IS CRACKED. THE DEVICE HAS NO PREVIOUS REPAIR HISTORY. 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 501(K): K190744.

    Additional Manufacturer Narrative · 0

    CORRECTED FIELDS: H4 (FROM JUL 9, 2021 TO JUL 19, 2021). 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, THE ROOT CAUSE COULD NOT BE DETERMINED AS THE REPORTABLE MALFUNCTION (PURPLE ARTIFACT) WAS NOT REPRODUCED. 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 TO THE OLYMPUS REPAIR CENTER FOR EVALUATION FOR A REPORTED COLORED IMAGE DEFECT, ¿PURPLE ARTIFACTS ON THE IMAGE¿. THE CUSTOMER REPORTED EVENT WAS FOUND AT AN UNSPECIFIED EVENT. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361756 VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 0°, AUTOCLAVABLE AUTOCLAVABLE VIDEO TELESCOPE HET OLYMPUS WINTER & IBE GMBH WA50040A 04042761074964

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown