MAUDE Adverse Event Report: NORTHGATE TECHNOLOGIES INC. CONMED GS2000; 50L ABDOMINAL INSUFFLATOR

Model Number	72-00258-0
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 03/06/2025 northgate technologies, inc was made aware of the alleged event, "gs2000 insufflator was being used, and c02 pressure could not be regulated properly and causing over pressure to the patient." upon follow up it was clarified that there was no patient injury, a device malfunction was not suspected and the procedure was completed with this device.The device history record for 94546lfi from (b)(6) 2021 (b)(4) was reviewed and the device passed all testing.Nothing out of the ordinary was noted.The device has not been returned to nti for repair / evaluation previously.There have been no other complaints reported to nti for this device.Nor-doc-dra-0027 risk analysis rev.H was reviewed.Risk id 7.8.1.10 refers to the risk of pressures associated with the unit and risk to the patient.The risk of those items related to high pressure (e.G., co2 absorption (intravasation), hypercapnia, subcutaneous emphysema, patients exposed to high pressure, etc.).These risks have been mitigated as follows: warning in manual on dangers of co2 absorption, embolism, idiosyncratic reactions, metabolic and cardiac reactionism overshoot is limited to fda recommendation not to exceed 45mmhg for more than 15 seconds., overpressure alert will activate at 5mmhg over the preset and a lapse of less than or equal to 5 seconds., multiple failures are required to cause overpressure of abdominal cavity.Temporary disabling of the overpressure alert will not exceed 30 seconds.If the device were to be displaying a higher pressure than actual that could be a loss of pneumo if the end user reduced the flow in an attempt to bring down the pressure.A clinical evaluation was performed per nor-doc-cer-0001 which proved the benefits outweigh the risks.The unit was evaluated by service and engineering (as documented in attached issue-2025-0015).Flow at 50 l/min was lower than specification - this would not have caused or contributed to the complaint issue.During evaluation - both of the mechanical prvs (main port and continuous pressure sensing line) were opening at a higher pressure than specification however this would not cause an overpressure situation, but they could contribute to it.The mechanical prvs are a redundant fail safe mechanisms which are design to vent pressure in high pressure situations if/ when the electronic pressure relief valves are unable to relieve pressure adequately.The complaint indicated that the continuous pressure sensing tubing line was not used during this procedure.Despite the malfunction of the mechanical prvs, the device relieved pressure as designed and intended during testing through the electronic pressure relief valves.This issue will continue to be monitored through the complaint system to assure patient safety.If further information were to become available, a follow-up report would be submitted.
Event or Problem Description
On 03/06/2025 northgate technologies, inc was made aware of the alleged event, "gs2000 insufflator was being used, and c02 pressure could not be regulated properly and causing over pressure to the patient." that occured on (b)(6) 2025 in australia.

• Brand Name: CONMED GS2000
• Common Device Name: 50L ABDOMINAL INSUFFLATOR
• Manufacturer (Section D): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL 60123
• Manufacturer (Section G): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL 60123
• Manufacturer Contact: todd gatto ; 1591 scottsdale court; elgin, IL 60123
• MDR Report Key: 22027329
• Report Number: 0001450997-2025-00004
• Device Sequence Number: 15731958
• Product Code: HIF
• UDI-Device Identifier: 20845854045395
• UDI-Public: 20845854045395
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K120151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 05/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 72-00258-0
• Device Catalogue Number: GS2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown