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

Model Number 72-00258-0

Device Problems Gas Output Problem (1266); Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

On 1/17/2024, northgate technologies was made aware of the following alleged issues "customer comments confirmed, additional issues found; pressure set, cps maintains indicator, overpressure and restriction indicator not functioning.The front bottom right-hand corner is chipped." despite requests for what "customer comments" was referring to no further information to date has been received.The device was evaluated by northgate on 02/26/2024 where it was found that the main port mechanical safety relief valve tubing was disconnected from the manifold barbed fitting and the main port mechanical safety relief valve loose in the device.This valve disconnection caused all flow rates to be lower than acceptable flow ranges.The valve is a mechanical safety mechanism in the device to ensure that pressure is maintained below 45 mmhg or less.The device has electronic pressure relief valves which ensure the pressure in the device is relieved when the pressure exceeds 3 mmhg above the preset.These were functioning as designed and expected in the subject device.The device history record for 92051fbe from june of 2017 (mo 12800) 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 was reviewed.Risk id 7.8.6.4 discusses loss of mechanical integrity causing the device to not perform to specification due to mechanical degradation with age.This could lead to the unit not able to maintain pneumoperitoneum resulting in delay of surgery.An fmea (nor-doc-dfmea-0025) was developed to identify any risks due to failure and a caution is in manual recommending yearly maintenance and calibration of the unit.A clinical evaluation was performed per nor-doc-cer-0001 which proved the benefits outweigh the risks.It is unknown how or when the mechanical safety relief valve was disconnected.This could have occured at the end user facility or during transit.The expected lifetime of the device is 6 years.This is the first instance where the main port mechanical valve was found disconnected from the tubing / manifold.This will continue to be trended and monitored.

Event Description

On 1/17/2024, northgate technologies was made aware of the following alleged issues "customer comments confirmed, additional issues found; pressure set, cps maintains indicator, overpressure and restriction indicator not functioning.The front bottom right-hand corner is chipped." despite requests for what "customer comments" was referring to no further information to date has been received.The device was evaluated by northgate on 02/26/2024 where it was found that the main port mechanical safety relief valve tubing was disconnected from the manifold barbed fitting and the main port mechanical safety relief valve loose in the device.

• Brand Name: CONMED GS2000
• Type of Device: 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 ; 8476088900
• MDR Report Key: 18979644
• MDR Text Key: 338615467
• Report Number: 0001450997-2024-00004
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 20845854045395
• UDI-Public: 20845854045395
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• 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?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1