BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE

    MDR report key: 17195774 · Received June 23, 2023

    Report

    Report Number
    9610773-2023-01730
    Event Type
    Malfunction
    Date Received
    June 23, 2023
    Date of Event
    June 15, 2023
    Report Date
    September 27, 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. THE E1 "TELEPHONE NUMBER," G2 AND H6 "COMPONENT CODE" AND "MEDICAL DEVICE PROBLEM CODE" FIELDS WERE CORRECTED BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INITIAL SUBMISSION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN MORE THAN 3 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, DEVICE MALFUNCTION WAS LIKELY ATTRIBUTABLE TO THE USE OF EXCESSIVE FORCE BY THE CUSTOMER. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND REPAIR. DURING THE EVALUATION, THE IMAGE WAS FOUND BLURRY. IN ADDITION, THERE WERE MANY BROKEN LIGHT TRANSMISSION FIBERS. THE ROOT OF THE TUBE WAS CORRODED AND BROKEN AND THE DIRECTION PIN WAS CORRODED. 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

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT A TELESCOPE HAD A BLURRY IMAGE. THE PATIENT WAS NOT UNDER SEDATION. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS IDENTIFIED: THE DIRECTION PIN WAS CORRODED. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1900127 TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE RIGID SCOPE GCP OLYMPUS WINTER & IBE GMBH A4674A 800775 04042761006361

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown