BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16765986 · Received April 18, 2023

    Report

    Report Number
    9610773-2023-01073
    Event Type
    Malfunction
    Date Received
    April 18, 2023
    Report Date
    July 19, 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
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPORTED PROBLEM WAS CONFIRMED AS THE BLACK COLORED EYEPIECE FUNNEL WAS FOUND BROKEN/FRACTURED AND SEPARATED FROM THE SCOPE. THE INSPECTION ALSO NOTED THE RIGID OUTER TUBE HAS DEFORMATION/DENTED (NON-REPORTABLE). THE REVIEW OF THE DEVICE HISTORY RECORDS FOR THE AFFECTED LOT OR SERIAL NUMBER WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUE. THE DEVICE WAS MANUFACTURED ACCORDING TO VALID INSTRUCTIONS AND MET ALL SPECIFICATIONS. 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 510(K): K923982/ K950076.

    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. IT HAS BEEN OVER 8 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY BROKEN EYEPIECE OCCURRED DUE TO THE USE OF EXCESSIVE FORCE BY THE CUSTOMER. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE HIGH-DEFINITION QUICK LOCK AUTOCLAVABLE TELESCOPE WAS RETURNED TO THE OLYMPUS REGIONAL REPAIR CENTER FOR A REPORTED ¿EYEPIECE OUT OF ORDER¿. THE CUSTOMER REPORTED PROBLEM WAS FOUND AT AN UNSPECIFIED EVENT. DURING INSPECTION, THE BLACK EYEPIECE FUNNEL WAS FOUND BROKEN/FRACTURED FROM THE SCOPE. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED TO OLYMPUS. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE BROKEN EYEPIECE FUNNEL FOUND DURING REPAIR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188187 TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE RIGID SCOPE EWY OLYMPUS WINTER & IBE GMBH WA53005A 667476 04042761052764

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown