BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 11200797 · Received January 20, 2021

    Report

    Report Number
    8010047-2021-01642
    Event Type
    Malfunction
    Date Received
    January 20, 2021
    Date of Event
    April 20, 2020
    Report Date
    January 20, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIF
    UDI-DI
    04953170140297
    PMA / PMN Number
    K014166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT FOR NON-FATAL SERIOUS INJURY/DEVICE MALFUNCTION HAS BEEN STORED UNDER THE COVID-19 PANDEMIC IN ACCORDANCE WITH THE GUIDANCE PUBLISHED BY FDA, POSTMARKETING ADVERSE EVENT REPORTING FOR MEDICAL PRODUCTS AND DIETARY SUPPLEMENTS DURING A PANDEMIC. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC REVIEWED THE MANUFACTURE HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED UPON THE INFORMATION FROM OLYMPUS (B)(4), THERE IS THE POSSIBILITY THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO DEVICE HANDLING AND/OR CONNECTION MISTAKE OF THE USER.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT A NURSE IN THE OPERATING ROOM FOUND THAT THERE WAS DISCHARGED LIQUID IN THE INSUFFLATION TUBE DURING A PREPARATION FOR CHOLECYSTECTOMY PROCEDURE AND AN ENGINEER OF THE FACILITY FOUND THAT THERE WAS WATER IN THE INTERNAL PIPE OF THE SUBJECT DEVICE. THE NURSE AND THE ENGINEER COULD NOT SPECIFY THE REASON. THE ENGINEER CONNECTED A CARBON DIOXIDE CYLINDER FOR GAS SUPPLY. THE GAS WAS SUPPLIED FOR 10 MINUTES, BUT THE LIQUID COULD NOT BE DISCHARGED. THE USER REPLACED THE SUBJECT DEVICE WITH A SPARE DEVICE AND COMPLETED THE INTENDED PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97054 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UHI-3 04953170140297

    Patients

    Seq Age Sex Outcome Treatment
    1