BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 19547178 · Received June 17, 2024

    Report

    Report Number
    3002808148-2024-05468
    Event Type
    Injury
    Date Received
    June 17, 2024
    Date of Event
    May 21, 2024
    Report Date
    October 10, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    HIF
    UDI-DI
    04953170140280
    PMA / PMN Number
    K014166
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1/ESTABLISHMENT NAME: (B)(6) MEDICAL AND (B)(6) HOSPITAL ADDED HERE DUE TO CHARACTER LIMITATION IN RESPECTIVE FIELD. THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S (LM) FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THIS SUPPLEMENTAL REPORT INCLUDES A CORRECTION TO A6 TO PROVIDE INFORMATION THAT WAS INADVERTENTLY NOT INCLUDED IN THE INITIAL MEDWATCH. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    QIT WAS REPORTED A PNEUMOTHORAX OCCURRED WHILE USING THE HIGH FLOW INSUFFLATION UNIT DURING A THERAPEUTIC LAPAROSCOPIC HERNIA REPAIR. WHEN LOOKING AT THE DEVICE'S SETTING TO CHECK THE CAUSE, IT WAS SET TO 15 MMHG WHICH WAS HIGHER THAN NORMAL. THE DOCTOR COMPLETED THE PROCEDURE WITH THE SAME DEVICE AND THE INCIDENT DID NOT EXTEND THE PROCEDURE. THE FACILITY'S UNDERSTAND WAS THE SETTINGS SHOULD NOT CHANGE AUTOMATICALLY, SO THEY THOUGHT IT WAS DUE TO HUMAN ERROR. IT WAS REPORTED THAT DEVICE DID NOT CHANGE THE PRESSURE TO 15 MMHG ON ITS OWN. THE PATIENT'S CONDITION WAS STABLE AND THERE WERE NO PROBLEMS AT THE TIME OF THIS REPORT. THE PATIENT'S HOSPITALIZATION WAS NOT EXTENDED DUE TO THE EVENT. INFORMATION REGARDING TREATMENT FOR THE PNEUMOTHORAX WAS REQUESTED, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1652274 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF SHIRAKAWA OLYMPUS CO., LTD. UHI-3 04953170140280

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other