BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE

    MDR report key: 16563303 · Received March 17, 2023

    Report

    Report Number
    9610773-2023-00779
    Event Type
    Malfunction
    Date Received
    March 17, 2023
    Date of Event
    February 16, 2023
    Report Date
    June 28, 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

    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 WAS UNABLE TO BE DETERMINED SINCE THE REPORTABLE MALFUNCTION WAS NOT CONFIRMED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO THE OLYMPUS REPAIR CENTER FOR EVALUATION AND THE CUSTOMER¿S REPORTED PROBLEM OF BROKEN OR DEFECTIVE COMPONENTS COULD NOT BE CONFIRMED. HOWEVER, THE INSPECTION DID CONFIRM THE RIGID OUTER TUBE IS DEFORMED/BENT, THE IMAGE IS BLURRY, AND THE INSPECTION FOUND THE LIGHT GUIDE CONNECTOR IS CONTAMINATED/CORRODED. 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): K897003/ K904939.

    Description of Event or Problem · 0

    OLYMPUS WAS INFORMED THAT THE CUSTOMER¿S WIDE ANGLE AUTOCLAVABLE TELESCOPE LIGHT GUIDE (LG) BUNDLE IS BROKEN INSIDE CAUSING LOW ILLUMINATION OF THE IMAGE AND THE INSERTION PART IS BENT¿. THE CUSTOMER REPORTED PROBLEM WAS FOUND DURING REGULAR INSPECTION AFTER A HYSTEROSCOPY PROCEDURE. THE FACILITY FINISHED THE PROCEDURE WITH ANOTHER DEVICE WITHOUT DELAY. NO DEATH OR INJURY OR HARM WAS REPORTED TO OLYMPUS (PATIENT WAS NOT UNDER SEDATION). THIS REPORT IS BEING SUBMITTED TO CAPTURE THE BROKEN LG BUNDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558960 TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE WIDE ANGLE AUTOCLAVABLE TELESCOPE GCP OLYMPUS WINTER & IBE GMBH A4674A 801258 04042761006361

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown OLYMPUS MODEL: CV-190.