BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM

    MDR report key: 14515524 · Received May 26, 2022

    Report

    Report Number
    1528319-2022-00028
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    April 27, 2022
    Report Date
    May 26, 2022
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    FCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOWING THE REPORTED EVENT, THE DEVICE WAS SENT TO THE MANUFACTURER FOR EVALUATIONS AND REPAIRS. THE CO2MPACT ENDOSCOPIC INSUFFLATOR® SYSTEM OPERATOR'S MANUAL (3180653) PROVIDES THE USER WITH THE FOLLOWING INFORMATION: "BEFORE EACH USE, THE FOLLOWING PROCEDURES OR INSPECTIONS SHOULD BE PERFORMED: VISUALLY INSPECT THE CO2MPACT ENDOSCOPIC INSUFFLATOR® SYSTEM FOR EXTERNAL SIGNS OF DAMAGE. INSPECT THE ELECTRICAL CONNECTIONS. DO NOT USE IF THE INSPECTION REVEALS DAMAGE. BEFORE CONNECTING THE POWER CORD TO THE WALL OUTLET, MAKE SURE THE MAIN POWER SWITCH IS OFF AND THAT THE VOLTAGE IS CORRECT. INSPECT THE CONNECTION TO THE CO2SUPPLY TANK, TO ASSURE IT IS INTACT AND TIGHT." ADDITIONALLY, THE CO2MPACT ENDOSCOPIC INSUFFLATOR® SYSTEM OPERATOR'S MANUAL (3180653) PROVIDES THE APPROPRIATE GAS FLOW SETTING FOR THE USER: "(3) USER-SELECTABLE SETTINGS: 2.0 (1.8-2.3) LITERS/MINUTE(LOW), 2.9 (2.7-3.1) LITERS/MINUTE (MEDIUM), 3.4 (3.2-3.6) LITERS/MINUTE (HIGH)." STERIS IS PENDING THE REPORT OF THE EVALUATIONS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 0

    THE CO2MPACT ENDOSCOPIC INSUFFLATOR WAS RETURNED TO THE CONTRACT MANUFACTURER FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE, IT WAS FOUND THAT THE UNIT COULD NOT BE POWERED ON, AND SURFACE DAMAGE WAS NOTED ON THE FRONT PANEL BEZEL. THE POWER SUPPLY, PRESSURE RELIEF VALVE, AND FRONT PANEL BEZEL WERE REPLACED, AND THE CO2MPACT ENDOSCOPIC INSUFFLATOR WAS RECALIBRATED AND FOUND TO BE OPERATING PROPERLY. THE DEVICE WAS RETURNED TO THE CUSTOMER AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE FLOW RATE ON THEIR CO2MPACT ENDOSCOPIC INSUFFLATOR WAS NOT OPERATING PROPERLY. USER FACILITY PERSONNEL UTILIZED ANOTHER UNIT CAUSING A DELAY IN THE PATIENT PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2763313 CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM FCX UNITED STATES ENDOSCOPY GROUP, INC. 710300

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown