BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE

    MDR report key: 16811348 · Received April 25, 2023

    Report

    Report Number
    9610773-2023-01139
    Event Type
    Malfunction
    Date Received
    April 25, 2023
    Report Date
    August 1, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GCP
    UDI-DI
    04042761006361
    PMA / PMN Number
    K904939
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE E1 "TELEPHONE NUMBER" FIELD WAS CORRECTED BASED ON INFORMATION AVAILABLE AT THE INITIAL REPORT SUBMISSION. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE EVENT OCCURRED DUE TO THE USE OF EXCESSIVE FORCE BY THE CUSTOMER. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    DURING THE OLYMPUS REPAIR INSPECTION, MISSING LIGHT GUIDE COVERGLASS WAS FOUND.. THE CUSTOMER¿S REPORTED PROBLEM WAS CONFIRMED, A DARK IMAGE IS DISPLAYED. ALSO, OTHER NON-REPORTABLE DEFECTS WERE NOTED, THE SERIAL NUMBER RING HAS FADED, THE LIGHT GUIDE CONNECTOR IS CONTAMINATED. 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): K790071/ K897003.

    Description of Event or Problem · 0

    THE CUSTOMER RETURNED THE WIDEANGLE AUTOCLAVABLE RIGID TELESCOPE TO OLYMPUS REPAIR CENTER FOR A ¿DARK IMAGE¿ DURING AN UNSPECIFIED PROCEDURE. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER WAS REPORTED.UPON INSPECTING AND TESTING, OLYMPUS IDENTIFIED A BROKEN OR LOOSE COMPONENTS ON THE MAIN BODY, MISSING LIGHT GUIDE COVERGLASS. THIS REPORT WAS SUBMITTED TO CAPTURE THE MISSING LIGHT GUIDE COVERGLASS FOUND DURING INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044566 TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE RIGID SCOPE GCP OLYMPUS WINTER & IBE GMBH A4674A 643444 04042761006361

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown