BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE

    MDR report key: 16565810 · Received March 17, 2023

    Report

    Report Number
    9610773-2023-00792
    Event Type
    Malfunction
    Date Received
    March 17, 2023
    Date of Event
    February 16, 2023
    Report Date
    July 6, 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. 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

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION, THE DEVICE EVALUATION, AND CORRECTIONS TO B5 AND G2. THE INFORMATION INCLUDED IN B5 AND G2 WAS INADVERTENTLY OMITTED FROM THE INITIAL MEDWATCH REPORT. PLEASE SEE UPDATES TO B5, G2, H3, H6, AND H10. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S COMPLAINT WAS NOT CONFIRMED. ADDITIONALLY, THE REPAIR CENTER FOUND THE INSERTION SECTION WAS BENT, THE LENS WAS DAMAGED CAUSING THE IMAGE TO SHOW A SHADOW, AND THE INSERTION SECTION HAD INDENTATIONS ON IT. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 3 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE BROKEN COMPONENTS WAS UNABLE TO BE IDENTIFIED.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 THE INSERTION PART DAMAGED. THE REPORTED ISSUE WAS FOUND DURING REPROCESSING AFTER USE OF THE DEVICE. THE FACILITY FINISHED THE PROCEDURE WITH THE SAME ONE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

    Description of Event or Problem · 0

    THE FIELD SERVICE REPRESENTATIVE CONFIRMED THAT NO DEVICE FRAGMENT FELL INTO THE PATIENT. ADDITIONALLY, IT WAS CONFIRMED THAT THE DAMAGED OCCURRED AFTER THE USE OF A HYSTEROSCOPY AND REPROCESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824946 TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE ENDOSCOPE GCP OLYMPUS WINTER & IBE GMBH A4674A 818291 04042761006361

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown