BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA HYSTEROVIDEOSCOPE

    MDR report key: 17259871 · Received July 5, 2023

    Report

    Report Number
    3002808148-2023-06700
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Report Date
    May 15, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    HIH
    UDI-DI
    04953170340185
    PMA / PMN Number
    K221557
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER¿S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS 9610595.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE CUSTOMER CONFIRMED THE HYF-V UNDERWENT ETQ GAS STERILIZATION. THE HYF-V WAS STERILIZED AFTER ATTACHING THE ETO CAP. THE CUSTOMER REALIZED THEY USED A DAMAGED ETO CAP AND IT WOULDN'T SEAT PROPERLY. 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 USER ATTACHED A DAMAGED EOG CAP TO THE SUBJECT DEVICE AND CONDUCTED STERILIZATION. IT HINDERED AIR DISCHARGING FROM INSIDE THE DEVICE TO OUTSIDE, CAUSING THE SUGGESTED EVENT. USER MAY DETECT THE EVENT BY FOLLOWING THESE INSTRUCTIONS FOR USE (IFU): VISERA HYSTEROVIDEOSCOPE HYF-V CHAPTER 3 PREPARATION AND INSPECTION 3.2 PREPARATION AND INSPECTION OF THE ENDOSCOPE_ INSPECTION OF THE ENDOSCOPE. USER MAY REDUCE/PREVENT OCCURRENCE OF THE SUGGESTED EVENT BY FOLLOWING THIS IFU: VISERA HYSTEROVIDEOSCOPE HYF-V CHAPTER 7 CLEANING, DISINFECTION AND STERILIZATION PROCEDURES 7.1 REQUIRED REPROCESSING EQUIPMENT_ INSPECTION OF THE EQUIPMENT. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE OLYMPUS REPRESENTATIVE ON BEHALF OF THE CUSTOMER REPORTED TO OLYMPUS, THE VISERA HYSTEROVIDEOSCOPE HAD A TORN LAVA RUBBER (THERE WAS EXPOSED INTERNAL METAL). THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1887696 VISERA HYSTEROVIDEOSCOPE HYSTEROVIDEOSCOPE HIH AIZU OLYMPUS CO., LTD. HYF-V 04953170340185

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown