BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 11566712 · Received March 24, 2021

    Report

    Report Number
    8010047-2021-04134
    Event Type
    Malfunction
    Date Received
    March 24, 2021
    Date of Event
    February 25, 2021
    Report Date
    May 25, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIF
    PMA / PMN Number
    K014166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. THE EXACT CAUSE OF THIS EVENT COULD NOT BE CONCLUSIVELY DETERMINED. BASED UPON THE INFORMATION FROM COMPLAINT, OMSC SURMISED THAT THE REPORTED PHENOMENON WAS OCCURRED THE FOLLOWING CAUSE. - DUE TO THE USE OF A NON-OLYMPUS FILTER, THE FOREIGN MATTER FLOWED BACK INTO THE TUBE. - DUE TO THE INFLUENCE OF THE CONNECTION STATUS BETWEEN THE DEVICE AND THE FILTER AND OTHER DEVICES, THE FOREIGN MATTER FLOWED BACK INTO THE TUBE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC WILL START EVALUATING THE DEVICE. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING THE PREPARATION FOR USE, A BROWN LIQUID WAS EJECTED FROM THE TUBE OF THE DEVICE WHEN THE USER INSUFFLATED CO2 BY THE DEVICE. THE USER COMPLETED THE PROCEDURE WITH THE DEVICE SINCE THE USER REPLACED THE TUBE AND FILTER OF THE DEVICE TO ANOTHER TUBE AND FILTER, AND A BROWN LIQUID DID NOT EJECT FROM THE TUBE OF THE DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT. THE USER REPORTED THAT THE FILTER WAS NON-OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456378 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UHI-3

    Patients

    Seq Age Sex Outcome Treatment
    1