BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONMED GS2000

    MDR report key: 18051936 · Received November 1, 2023

    Report

    Report Number
    0001450997-2023-00006
    Event Type
    Injury
    Date Received
    November 1, 2023
    Date of Event
    September 18, 2023
    Report Date
    November 1, 2023
    Manufacturer
    NORTHGATE TECHNOLOGIES INC.
    Product Code
    HIF
    UDI-DI
    20845854045395
    PMA / PMN Number
    K120151
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 02OCT2023 NORTHGATE TECHNOLOGIES, INC WAS MADE AWARE OF THE ALLEGED EVENT THAT OCCURRED IN AUSTRALIA. BASED ON THE INFORMATION PROVIDED THROUGH 01NOV2023, THERE HAS BEEN A REPORT OF A PATIENT INJURY AND POSSIBLE MALFUNCTION OF THE DEVICE PRESSURE READING, HOWEVER DESPITE MULTIPLE ATTEMPTS TO GET FURTHER CLARIFICATION AROUND THE TYPE AND NATURE OF THE INJURY AND USAGE OF THE DEVICE NO FURTHER INFORMATION IS AVAILABLE. THE REPORTED DEVICE IS BEING RETURNED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY. THE DEVICE HISTORY RECORD FOR (B)(6) FROM FEBRUARY OF 2014 (MO 11317) WAS REVIEWED AND THE DEVICE PASSED ALL TESTING. NOTHING OUT OF THE ORDINARY WAS NOTED. THE DEVICE HAS BEEN RETURNED TO NTI FOR REPAIR / EVALUATION PREVIOUSLY FOR SOFTWARE UPGRADE UNDER RMA 31128 ((B)(6) 2018) AND THE UNIT REQUIRED REPLACEMENT OF PROPORTIONAL VALVE AND VALVE CONTROLLER PCB. THE UNIT WAS RECALIBRATED AFTER SOFTWARE UPGRADES AND PASSED ALL FQC TESTING. THE UNIT WAS UPDATED FROM REV C TO REV E. THE DEVICE WAS RETURNED TO NTI VIA RMA 33951 ((B)(6) 2022) WITH COMPLAINT OF DEVICE NOT GIVING CORRECT READING. COMPLAINT WAS NOT VERIFIED DEVICE PERFORMED AS EXPECTED. HOWEVER, THE DEVICE MEMORY INDICATED F12 (PRESSURE FAULT) AS OCCURRING ONCE. FAULT CODE #12 WAS NOT REPRODUCED. MINOR COSMETIC DAMAGE WAS NOTED. REPAIRS WERE COMPLETED BY REPLACING THE BEZEL, OVERLAY, TOUCHSCREEN. THE DEVICE WAS RECALIBRATED AND PASSED ALL FQC INSPECTIONS AND TESTING.

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2023 NORTHGATE TECHNOLOGIES, INC WAS MADE AWARE OF THE ALLEGED EVENT THAT OCCURRED IN AUSTRALIA. BASED ON THE INFORMATION PROVIDED THROUGH (B)(6) 2023, THERE HAS BEEN A REPORT OF A PATIENT INJURY AND POSSIBLE MALFUNCTION OF THE DEVICE PRESSURE READING, HOWEVER DESPITE MULTIPLE ATTEMPTS TO GET FURTHER CLARIFICATION AROUND THE TYPE AND NATURE OF THE INJURY AND USAGE OF THE DEVICE NO FURTHER INFORMATION IS AVAILABLE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY. THE DEVICE HISTORY RECORD FOR (B)(6) FROM (B)(6) 2014 ((B)(6)) WAS REVIEWED AND THE DEVICE PASSED ALL TESTING. NOTHING OUT OF THE ORDINARY WAS NOTED. THE DEVICE HAS BEEN RETURNED TO NTI FOR REPAIR / EVALUATION PREVIOUSLY FOR SOFTWARE UPGRADE UNDER RMA 31128 ((B)(6) 2018) AND THE UNIT REQUIRED REPLACEMENT OF PROPORTIONAL VALVE AND VALVE CONTROLLER PCB. THE UNIT WAS RECALIBRATED AFTER SOFTWARE UPGRADES AND PASSED ALL FQC TESTING. THE UNIT WAS UPDATED FROM REV C TO REV E. THE DEVICE WAS RETURNED TO NTI VIA RMA 33951 ((B)(6) 2022) WITH COMPLAINT OF DEVICE NOT GIVING CORRECT READING. COMPLAINT WAS NOT VERIFIED DEVICE PERFORMED AS EXPECTED. HOWEVER, THE DEVICE MEMORY INDICATED F12 (PRESSURE FAULT) AS OCCURRING ONCE. FAULT CODE #12 WAS NOT REPRODUCED. MINOR COSMETIC DAMAGE WAS NOTED. REPAIRS WERE COMPLETED BY REPLACING THE BEZEL, OVERLAY, TOUCHSCREEN. THE DEVICE WAS RECALIBRATED AND PASSED ALL FQC INSPECTIONS AND TESTING. THE DEVICE WAS RECEIVED AT NTI ON (B)(6) 2023. THE DEVICE EVALUATION DID NOT FIND ANY MALFUNCTIONS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO A HYPERDISTENDED ABDOMEN. THE PRESSURE SENSING AND VENTING SAFETY FEATURES IN THE DEVICE WERE TESTED AND OPERATED AS DESIGNED. THE ITEMS NOTED DURING SERVICE (E.G., FAULT CODE 10, LOW FLOW AT 5 LPM, REGULATOR DEBRIS, REGULATOR PRESSURE RELIEF VALVE VENTING EARLY) WOULD NOT HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT EVENT. THE INSUFFLATOR HAS 2 MAIN SAFETY MECHANISMS THE FIRST IS THE ELECTRONIC (SOFTWARE) CONTROLLED PRESSURE RELIEF MECHANISM WHICH WAS DESIGNED TO ENSURE PRESSURE RELIEF AT MAX PRESSURE OR WHEN PATIENT PRESSURE EXCEEDS SET PRESSURE BY MORE THAN 3 MMHG FOR MORE THAN 5 SEC . THIS IS WHAT IS REFERRED TO IN THE OPERATORS MANUAL AND IS DEPENDENT UPON THE SET PRESSURE OF THE DEVICE AND THE MAGNITUDE AND DURATION OF THE OVER PRESSURE CONDITION. THE SECOND SAFETY MECHANISM IS A MECHANICAL PRESSURE RELIEF VALVE THAT IS INTENDED TO ENSURE THAT PRESSURE OVERSHOOT DOES NOT EXCEED 45 MMHG FOR MORE THAN 15 SECONDS WHEN ESTABLISHING PNEUMOPERITONEUM. THESE WERE OPERATING AS DESIGNED AND INTENDED WHEN TESTED.

    Description of Event or Problem · 0

    ON 02OCT2023 NORTHGATE TECHNOLOGIES WAS MADE AWARE OF THE FOLLOWING ALLEGED EVENT " THE PATIENT WAS INJURED HOWEVER HOSPITAL CONTACT WOULD NOT PROVIDE SPECIFICS." "DEVICE MONITOR DISPLAYED -9MMHG HOWEVER THE PATIENT WAS CLEARLY HYPER-DISTENDED. PROCEDURE STOPPED AND THE DEVICE WAS RESET [?][?][?][?]THE SAME ISSUE HAPPENED AGAIN. THEATRE TECH SWAPPED OUT THE UNIT FOR ANOTHER GS2000 HOWEVER THIS DIDN'T OPERATE CORRECTLY EITHER [REDACTED HOSPITAL CONTACT] BELIEVES THIS MAY HAVE BEEN DUE TO INCORRECT SETUP OF GAS SUPPLY BUT WILL BE RETURNING [THE DEVICE] FOR INSPECTION REGARDLESS." THE EVENT OCCURRED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2091289 CONMED GS2000 50L ABDOMINAL INSUFFLATOR HIF NORTHGATE TECHNOLOGIES INC. 72-00258-0 20845854045395

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown