BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE

    MDR report key: 17054428 · Received June 2, 2023

    Report

    Report Number
    9610773-2023-01530
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    May 17, 2023
    Report Date
    July 31, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GCP
    UDI-DI
    04042761006361
    PMA / PMN Number
    K790071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND REPAIR. DURING THE EVALUATION, IT WAS FOUND THAT IMAGE HAD SHADOW DUE TO BROKEN AND DISPLACED LENS. THE EYEPIECE CUP HAD DENTS AND THE GUIDE SCREW WAS BROKEN. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, THE ROOT CAUSE OF THE REPORTED DEFECT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. IN GENERAL, THE CUSTOMER IS REQUIRED TO INSPECT THE DEVICE FOR DEFECTS, CHECK THE FUNCTION OF ALL DEVICES AND HAVE ALTERNATE EQUIPMENT PRIOR TO USE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE. ADDITIONAL PMA/510(K): K897003/ K904939.

    Additional Manufacturer Narrative · 0

    CORRECTED FIELDS: D10 (INADVERTENTLY MISSED ON THE INITIAL), G2 (ADDED MISSED SELECTION). 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. EVENT 1: THE FRONT COVER GLASS WAS REPORTED AS DAMAGED. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED AS THIS EVENT WAS NOT CONFIRMED OR REPRODUCED. EVENT 4: THE GUIDE SCREW WAS BROKEN. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED. IT IS LIKELY THE EVENT OCCURRED DUE TO THE USE OF EXCESSIVE FORCE BY THE CUSTOMER. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT A TELESCOPE HAD AN ABNORMAL IMAGE AND DAMAGE TO THE FRONT COVER GLASS. THE REPORTED PROBLEM WAS FOUND DURING INSPECTION BEFORE USE. THE INTENDED PROCEDURE IS UTERINE CAVITY EXAMINATION. THE FACILITY FINISHED THE PROCEDURE WITH ANOTHER ONE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1896800 TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE RIGID SCOPE GCP OLYMPUS WINTER & IBE GMBH A4674A 805358 04042761006361

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown VISERA ELITE VIDEO PROCESSOR (OTV-S190)