BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE

    MDR report key: 17241542 · Received June 30, 2023

    Report

    Report Number
    9610773-2023-01777
    Event Type
    Malfunction
    Date Received
    June 30, 2023
    Report Date
    September 28, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    EWY
    UDI-DI
    04042761052764
    PMA / PMN Number
    K912362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 AND CORRECTION TO E1 AND G2. CORRECTION: CORRECTED E1 TO TRANSLATE TO ENGLISH. CHECKED "OTHER" TO ADD THE COUNTRY JAPAN. 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, IT IS LIKELY THE EVENT OCCURRED DUE TO THE USER IMPROPERLY HANDLING AND APPLYING EXCESSIVE FORCE TO THE SUBJECT DEVICE. 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 REPORTED ISSUE WAS CONFIRMED, THE EYEPIECE WAS FOUND DAMAGED. THE IMAGE FAILURE WAS ALSO TRACED BACK TO COVER GLASS ADHESION. 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): K923982/ K950076.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT A TELESCOPE HAD PARTIAL EYEPIECE DAMAGE. IT IS UNKNOWN WHEN THE REPORTED ISSUE WAS FOUND. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS. THIS MEDWATCH IS BEING SUBMITTED FOR THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23537 TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE RIGID SCOPE EWY OLYMPUS WINTER & IBE GMBH WA53005A 517387 04042761052764

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown