BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS INSUFLATOR

    MDR report key: 1706725 · Received May 25, 2010

    Report

    Report Number
    8010047-2010-00099
    Event Type
    Malfunction
    Date Received
    May 25, 2010
    Date of Event
    April 27, 2010
    Report Date
    April 27, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFO REGARDING THE REPORT, BUT RECEIVED ONLY LIMITED INFO. USER FACILITY PERSONNEL STATED THAT THE PT HAD REQUIRED INTERVENTION FOLLOWING THE EVENT, BUT THERE WAS NO PERMANENT INJURY REPORTED. THE SUBJECT DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION. OLYMPUS WAS INFORMED THAT USER FACILITY BIOMEDICAL ENGINEERS HAD TESTED THE INSUFFLATION UNIT FOLLOWING THE PROCEDURE, AND NO PROBLEM WAS FOUND. THE TUBING USED WITH THE DEVICE DURING THE PROCEDURE WAS SAID TO HAVE BEEN DISCARDED. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED. THE USER FACILITY HAS NOT SPECIFIED IF THE DEVICE WILL BE RETURNED FOR EVAL. IF THE DEVICE IS RETURNED FOR EVAL, OF IF SIGNIFICANT ADDITIONAL INFO IS OBTAINED, THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS AN MDR IN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING AN UNSPECIFIED SURGERY IN WHICH THE SUBJECT DEVICE WAS SAID TO BE USED, THE USERS REPORTEDLY OBSERVED THE ABDOMINAL PRESSURE EXCEEDED THE SET LIMIT WITHOUT THE DEVICE ISSUING AN ALARM OR ACTIVATING THE PRESSURE RELIEF. THE USERS REMOVED THE PATIENT TUBING FROM THE INSUFFLATOR TO STOP THE FLOW OF GAS TO THE PATIENT. THE DEVICE WAS REMOVED FROM SERVICE, AND THE PATIENT REPORTEDLY REQUIRED UNSPECIFIED SURGERY BY OTHER MEANS. THE STATUS OF THE PATIENT IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS INSUFLATOR INSUFLATOR FCX OLYMPUS MEDICAL SYSTEMS CORPORATION UHI-3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention