BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 14363557 · Received May 11, 2022

    Report

    Report Number
    8010047-2022-08078
    Event Type
    Injury
    Date Received
    May 11, 2022
    Date of Event
    April 12, 2022
    Report Date
    July 7, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIF
    PMA / PMN Number
    K122180
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT DEVICES: (NO MALFUNCTION REPORTED), CLV-S190 7202393, UHI-4 7211038, IMH-20 7100784, LTF-S190-5 2201171, OTV-S190 7232607, OEV261H 7245546, OEV261H 7245572. PHYSICAL EVALUATION OF SUSPECT DEVICE: VISUAL INSPECTION: THERE WAS NO ABNORMALITY IN THE APPEARANCE. ACTUAL MACHINE CONFIRMATION: THE REPORTED PROBLEM WAS REPRODUCED. NO FURTHER TESTING COULD BE CONDUCTED BECAUSE THE DEVICE WOULD NOT LIGHT UP. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING UPDATED TO PROVIDE INVESTIGATION FINDINGS. NEW INFORMATION IS REPORTED IN H6 AND H10. THE DEVICE HISTORY RECORD (DHR) FOR THE COMPLAINT DEVICE HAS BEEN REVIEWED AND IT IS CONFIRMED THAT THE DEVICE MET ALL DESIGN AND QUALITY SPECIFICATION WHEN IT WAS SHIPPED. THE SUSPECT DEVICE HAS NOT BEEN EVALUATED OR REPAIRED BY OLYMPUS IN THE PAST YEAR. CONCLUSION: THE DEFINITIVE CAUSE OF THE REPORTED EVENTS COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS DURING A LAPAROSCOPIC ASSISTED SURGERY USING A HIGH FLOW INSUFFLATION UNIT, AT THE STAGE OF OBSERVING THE INSIDE OF THE ABDOMINAL CAVITY, THE ALARM OF THE INSUFFLATION DEVICE SUDDENLY SOUNDED AND THE AIR SUPPLY STOPPED WITH ALL THE NUMBERS AND OTHER DISPLAYS DISAPPEARING. THE UNIT WAS RESTARTED AND THE SAME THING HAPPENED AGAIN. AFTER THIS, THE PHYSICIAN SWITCHED TO A SMALL LAPAROTOMY INCISION AND SUCCESSFULLY COMPLETED THE PROCEDURE WITH NO ADVERSE EFFECTS TO THE PATIENT. THERE WAS NO REPORTED MALFUNCTION OF ANY CONCOMITANT DEVICE USED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1790223 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UHI-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other