BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16807897 · Received April 25, 2023

    Report

    Report Number
    9610773-2023-01132
    Event Type
    Malfunction
    Date Received
    April 25, 2023
    Date of Event
    March 26, 2023
    Report Date
    August 2, 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
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND TO CORRECT G2. DURING DEVICE INSPECTION, THE CUSTOMER'S COMPLAINT WAS NOT CONFIRMED. OLYMPUS FOUND THE LIGHT GUIDE CONNECTOR ON THE MAIN BODY WAS DETACHED AND THE IMAGE APPEARED BLURRY DUE TO PARTICLES IN OPTICAL SYSTEM. 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 OF THE SUGGESTED EVENT COULD NOT BE CONCLUDED, ALTHOUGH IT CAN BE PRESUMED THAT THE DEFECT WAS CAUSED DUE TO EXCESSIVE FORCE BY THE CUSTOMER. THE CUSTOMER'S COMPLAINT AND IMAGE ISSUE ARE NOT REPORTABLE EVENTS. PER THE LEGAL MANUFACTURER, THERE IS NO POTENTIAL FOR THESE ISSUES TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF THE MALFUNCTIONS WERE TO RECUR. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    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): K923982/ K950076.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT A TELESCOPE COULDN¿T GET CONNECTION PIECE OFF THE LIGHT CABLE ATTACHMENT. IT IS UNKNOWN WHEN THE REPORTED ISSUE OCCURRED. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1210284 TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE MEDIASTINOSCOPE EWY OLYMPUS WINTER & IBE GMBH WA53005A 672250 04042761052764

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown