BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM

    MDR report key: 13590985 · Received February 24, 2022

    Report

    Report Number
    1528319-2022-00011
    Event Type
    Malfunction
    Date Received
    February 24, 2022
    Date of Event
    January 25, 2022
    Report Date
    February 24, 2022
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    FCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THROUGH FOLLOW-UP, STERIS ENDOSCOPY LEARNED THAT FACILITY PERSONNEL FOUND THE ISSUE THE NEXT DAY WHEN THEY WENT TO UTILIZE THE INSUFFLATOR SYSTEM FOR A PATIENT PROCEDURE. THE SYSTEM WAS READING EMPTY RESULTING IN A PROCEDURE DELAY. THE CONNECTION WAS TIGHTENED AND NO FURTHER AIR LEAK WAS NOTED. A STERIS ENDOSCOPY PRODUCT SPECIALIST ARRIVED ONSITE AND SPOKE WITH USER FACILITY. THE SPECIALIST LEARNED THAT THE USER FACILITY DID NOT REMOVE THE EXISTING POST VALVE GASKET ON THE CO2 SUPPLY TANK. INSTEAD THEY INSTALLED THE HOSE AND YOKE ASSEMBLY ON TOP OF THE EXISTING GASKET SEAL, WHICH DID NOT ALLOW THE YOKE TO FULLY CONNECT TO THE TANK RESULTING IN THE REPORTED EVENT. A STERIS ENDOSCOPY FIELD SERVICE ENGINEER COUNSELED FACILITY PERSONNEL ON PROPER MAINTENANCE OF THE INSUFFLATOR SYSTEM. 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 INSPECTION REVEALS DAMAGE." NO ADDITIONAL ISSUES HAVE BEEN NOTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT CO2 WAS LEAKING FROM THE CO2 SOURCE TANK WHILE CONNECTED TO THE CO2MPACT UNIT WITH HOSE AND YOKE ASSEMBLY, RESULTING IN A PROCEDURE DELAY. NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300025 CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM FCX UNITED STATES ENDOSCOPY GROUP, INC. 710300

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown