BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS CYLINDER HOSE FOR UHI-3

    MDR report key: 1949095 · Received December 30, 2010

    Report

    Report Number
    8010047-2010-00262
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    November 5, 2010
    Report Date
    December 9, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) CONTACTED THE USER FACILITY TO OBTAIN ADD'L INFO. THE USER FACILITY REPORTED THAT THE USERS WERE NOT AWARE THAT THE AIRTIGHT PACKING FELL OFF THE CONNECTOR WHEN ATTACHING IT TO THE CYLINDER. THE USER FACILITY STATED THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO USER HANDLING. THE AIRTIGHT PACKING WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC). OLYMPUS WAS UNABLE TO PERFORM AN EVAL AS ONLY PARTIAL DEVICE WAS REC'D. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC COLECTOMY PROCEDURE, THE USERS EXPERIENCED INSUFFICIENT GAS SUPPLY WHILE INSUFFLATING THE ABDOMINAL CAVITY. THE CLINICAL ENGINEER DETACHED THE CO2 CYLINDER FROM THE MAJ-1080 AND THEN ATTACHED A NEW GAS CYLINDER. A GAS LEAK WAS NOTED FROM THE YOKE, AND THE PT WAS UNABLE TO BE INSUFFLATED. THE PROCEDURE WAS CONVERTED TO AN OPEN ABDOMINAL SURGERY. THE PT REPORTEDLY RECOVERED WELL AND HAD BEEN RELEASED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS CYLINDER HOSE FOR UHI-3 CYLINDER HOSE CCW OLYMPUS MEDICAL SYSTEMS CORPORATION MAJ-1080 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR OLYMPUS HIGH FLOW INSUFFLATION UNIT WITH| SERIAL NUMBER (B)(4)