MAUDE Adverse Event Report: NORTHGATE TECHNOLOGIES, INC. 50L ABDOMINAL INSUFFLATOR; INSUFFLATOR, LAPAROSCOPIC

Catalog Number GS2000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bradycardia (1751)

Event Date 10/19/2021

Event Type  Injury  

Event Description

The customer reported that the device, gs2000, 50l abdominal insufflator, was used during a bilateral tubal ligation on (b)(6) 2021 when it was reported ¿during surgery the screen had 3 choices and there was a little square in the right-hand corner.They hit that square and the system rebooted, and they saw a familiar screen so they started the case.The pressure kept fluctuating.The patient went into bradycardia.The patient is fine now.¿ further assessment questions found that the device was administering 40+ mmhg to the patient.This increased the abdominal pressure and caused profound bradycardia per the reporter.The patient was treated with robinul, atropine.There was a 20-minute delay in the procedure when it was determined the procedure was not able to be completed laparoscopically.The procedure was converted to an open procedure.The patient had an extended hospital stay of 2-hours.This report is being raised on the basis of injury due to conversion to an open procedure.

Manufacturer Narrative

The reported device is being returned to conmed 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.

Manufacturer Narrative

Correction: d3 and g1, correction to manufacturer name, address and contact information.The reported device is being returned to conmed 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.

Event Description

The customer reported that the device, gs2000, 50l abdominal insufflator, was used during a bilateral tubal ligation on (b)(6) 2021 when it was reported ¿during surgery the screen had 3 choices and there was a little square in the right-hand corner.They hit that square and the system rebooted, and they saw a familiar screen so they started the case.The pressure kept fluctuating.The patient went into bradycardia.The patient is fine now.¿ further assessment questions found that the device was administering 40+ mmhg to the patient.This increased the abdominal pressure and caused profound bradycardia per the reporter.The patient was treated with robinul, atropine.There was a 20-minute delay in the procedure when it was determined the procedure was not able to be completed laparoscopically.The procedure was converted to an open procedure.The patient had an extended hospital stay of 2-hours.This report is being raised on the basis of injury due to conversion to an open procedure.

Event Description

The customer reported that the device, gs2000, 50l abdominal insufflator, was used during a bilateral tubal ligation on (b)(6) 2021 when it was reported ¿during surgery the screen had 3 choices and there was a little square in the right-hand corner.They hit that square and the system rebooted, and they saw a familiar screen so they started the case.The pressure kept fluctuating.The patient went into bradycardia.The patient is fine now.¿ further assessment questions found that the device was administering 40+ mmhg to the patient.This increased the abdominal pressure and caused profound bradycardia per the reporter.The patient was treated with robinul, atropine.There was a 20-minute delay in the procedure when it was determined the procedure was not able to be completed laparoscopically.The procedure was converted to an open procedure.The patient had an extended hospital stay of 2-hours.This report is being raised on the basis of injury due to conversion to an open procedure.

Manufacturer Narrative

Preventive maintenance is not overdue.No fault found with device.A device history record review was requested from the manufacturer, and no response was received.The service history was reviewed, and no previous service data was found.(b)(4).Per the instructions for use, the user is advised that the cps symbol is displayed when the cps tubing is connected and the insufflator senses pressure greater than 5 mm hg.The cps function provides a separate means to determine and sense pressure which is typically done through the insufflation tubing set.This results in a more efficient process with quicker recovery to lost pressure should that occur.The repeated abdominal wall breathing effect of standard insufflation is also dramatically reduced.When using this device, the best protection against overpressurization at the operative site is to use direct pressure monitoring (via the cps tubing set).At flow rates greater than 20l/minute the in-line warmer may not be able to warm the co2 gas to body temperature.Subsequently, there is no greater risk to the patient.It would be as if there were no warmer at all.This issue will continue to be monitored through the complaint system to assure patient safety.

Manufacturer Narrative

Correction due to original equipment manufacturer (oem) report received: h10 - device evaluation updated: an evaluation was conducted by the manufacturer, northgate technologies, and found the unit functions as expected.No adverse or abnormal operation was observed when operating at various setpoint pressures and flow rates.H10 - device history record review found no abnormalities by the oem.Preventive maintenance is not overdue.No fault found with device.The service history was reviewed, and no previous service data was found.A two-year review of complaint history revealed there has been a total of one complaint, regarding one device, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised that the cps symbol is displayed when the cps tubing is connected and the insufflator senses pressure greater than 5 mm hg.The cps function provides a separate means to determine and sense pressure which is typically done through the insufflation tubing set.This results in a more efficient process with quicker recovery to lost pressure should that occur.The repeated abdominal wall breathing effect of standard insufflation is also dramatically reduced.When using this device, the best protection against overpressurization at the operative site is to use direct pressure monitoring (via the cps tubing set).At flow rates greater than 20l/minute the in-line warmer may not be able to warm the co2 gas to body temperature.Subsequently, there is no greater risk to the patient.It would be as if there were no warmer at all.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported that the device, gs2000, 50l abdominal insufflator, was used during a bilateral tubal ligation on (b)(6) 2021 when it was reported ¿during surgery the screen had 3 choices and there was a little square in the right-hand corner.They hit that square and the system rebooted, and they saw a familiar screen so they started the case.The pressure kept fluctuating.The patient went into bradycardia.The patient is fine now.¿ further assessment questions found that the device was administering 40+ mmhg to the patient.This increased the abdominal pressure and caused profound bradycardia per the reporter.The patient was treated with robinul, atropine.There was a 20-minute delay in the procedure when it was determined the procedure was not able to be completed laparoscopically.The procedure was converted to an open procedure.The patient had an extended hospital stay of 2-hours.This report is being raised on the basis of injury due to conversion to an open procedure.

• Brand Name: 50L ABDOMINAL INSUFFLATOR
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 12770091
• MDR Text Key: 283484544
• Report Number: 1017294-2021-00354
• Device Sequence Number: 1
• Product Code: HIF
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: GS2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 11/08/2021
• Supplement Dates Manufacturer Received: 10/19/2021; 11/15/2021; 01/19/2022
• Supplement Dates FDA Received: 11/08/2021; 12/07/2021; 02/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic