BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CO2MPACT

    MDR report key: 22541037 · Received July 18, 2025

    Report

    Report Number
    1528319-2025-00077
    Event Type
    Malfunction
    Date Received
    July 18, 2025
    Date of Event
    June 19, 2025
    Report Date
    July 18, 2025
    Manufacturer
    US ENDOSCOPY
    Product Code
    FCX
    UDI-DI
    00724995180362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE SUBJECT OF THE REPORTED EVENT WAS SENT TO THE SUPPLIER FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE CO2EFFICIENT ENDOSCOPIC INSUFFLATOR UNIT SUBJECT OF THE REPORTED EVENT WAS RETURNED TO STERIS FOR EVALUATION. THE REPORTED EVENT COULD NOT BE DUPLICATED; HOWEVER, THE UNIT'S MEMBRANE DID NOT PERFORM AS EXPECTED. THE MEMBRANE WAS REPLACED AND THE DEVICE WAS RECALIBRATED AND TESTED PRIOR TO BEING RETURNED TO THE CUSTOMER. THE CO2EFFICIENT ENDOSCOPIC INSUFFLATOR OPERATOR MANUALS STATES, "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)." A 3-YEAR COMPLAINT REVIEW INDICATES THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR CO2 EFFICIENT ENDOSCOPIC INSUFFLATOR SYSTEM WAS INTERMITTENTLY SHUTTING OFF RESULTING IN A PROCEDURE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396173 CO2MPACT CO2EFFICIENT ENDOSCOPIC INSUFFLATOR SYSTEM FCX US ENDOSCOPY 710300 00724995180362

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown