BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELESCOPE "OES ELITE", 4 MM, 30°, HD, AUTOCLAVABLE

    MDR report key: 16109824 · Received January 5, 2023

    Report

    Report Number
    9610773-2023-00107
    Event Type
    Malfunction
    Date Received
    January 5, 2023
    Date of Event
    December 8, 2022
    Report Date
    March 24, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FGC
    UDI-DI
    04042761077545
    PMA / PMN Number
    K151191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS (DHR) WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUES. DURING THE REPAIR INSPECTION, THE CUSTOMER¿S REPORTED PROBLEM OF ¿BROKEN PLAN GLASS AT TUBE¿ COULD NOT BE CONFIRMED AS THERE WAS NO DAMAGED TO THE DISTAL END COVERGLASS OF THE OUTER TUBE. HOWEVER, THE INSPECTION FOUND BROKEN LENS INSIDE THE OPTICAL SYSTEM ATTRIBUTING TO A BLURRY IMAGE. THE EXACT CAUSE OF THE BROKEN LENS IS UNKNOWN, HOWEVER, EXCESSIVE FORCE BY THE CUSTOMER CANNOT BE RULED OUT. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE REFERENCED TELESCOPE WAS RETURNED TO THE OLYMPUS REPAIR CENTER. THE REPAIR INSPECTION FOUND THE IMAGE IS BLURRED DUE TO BROKEN INTERNAL OPTICAL LENS. THE INVESTIGATION IS IN PROGRESS; THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. 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.

    Description of Event or Problem · 0

    THE OLYMPUS (OVN) FIELD SERVICE ENGINEER WAS INFORMED BY THE NURSE AT THE USER FACILITY THAT THE CUSTOMER OES ELITE, HIGH-DEFINITION AUTOCLAVABLE TELESCOPE HAS A ¿BROKEN PLAN GLASS AT TUBE¿. THE CUSTOMER REPORTED PROBLEM WAS FOUND AT INSPECTION BEFORE USE. NO DEATH INJURY OR INFECTION AND NO IMPACT TO PERSON OR OTHER HAS BEEN REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523120 TELESCOPE "OES ELITE", 4 MM, 30°, HD, AUTOCLAVABLE HD TELESCOPE FGC OLYMPUS WINTER & IBE GMBH WA2T430A 811235 04042761077545

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown