BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELESCOPE, 30°, 4 MM

    MDR report key: 16162793 · Received January 13, 2023

    Report

    Report Number
    9610773-2023-00225
    Event Type
    Malfunction
    Date Received
    January 13, 2023
    Date of Event
    December 16, 2022
    Report Date
    May 12, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761020855
    PMA / PMN Number
    K897003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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. 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 DEFINITIVE ROOT CAUSE OF THE CHIPPED LENS COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE DAMAGED WAS CAUSED BY THE APPLICATION OF EXCESSIVE FORCE BY THE USER. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE REFERENCED DEVICE WAS RETURNED TO THE OLYMPUS SERVICE CENTER. THE SERVICE INSPECTION CONFIRMED THE CUSTOMER¿S REPORTED ISSUE, THE IMAGE IS BLURRY DUE TO A CHIPPED LENS FOUND INSIDE THE OPTICAL SYSTEM (NO MOISTURE OBSERVED). THE INSPECTION ALSO NOTED THE RIGID OUTER TUBE SHAFT IS BENT, LIGHT GUIDE FIBER BUNDLE BREAKAGE AND SCRATCHES AT THE DISTAL TIP, AND DENTS ON THE EYEPIECE FUNNEL. 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.

    Description of Event or Problem · 0

    OLYMPUS WAS INFORMED THAT THE CUSTOMER AUTOCLAVABLE RIGID TELESCOPE HAS A BROKEN COMPONENT DEFECT, ¿THE LENS IS CRACKED¿. THE CUSTOMER REPORTED DEFECT WAS FOUND AT REPROCESSING. NO DEATH OR INJURY AND NO IMPACT TO PERSON OR OTHER WAS REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1964847 TELESCOPE, 30°, 4 MM AUTOCLAVABLE RIGID TELESCOPE HIH OLYMPUS WINTER & IBE GMBH A22002A 617666 04042761020855

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown