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

Catalog Number GS2000

Device Problem Insufficient Information (3190)

Patient Problem Bradycardia (1751)

Event Date 06/03/2022

Event Type  Injury  

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.

Event Description

The sales representative reported on behalf of the customer that the device, gs2000, 50l abdominal insufflator was being used on (b)(6) 2022 and "patient experienced bradycardia¿.The procedure was completed with an alternate same device.There was a 2 minute delay.There was no impact or injury to the patient or user.The procedure was completed.Further assessment has been sent; however, to date no information has been obtained.This report is being raised on the basis of injury due to bradycardia.

Manufacturer Narrative

The device evaluation found no fault with the device.A device history record was requested from the manufacturer; and no abnormalities were communicated.The service history was reviewed and found similar repairs to this unit previously.A two-year review of complaint history revealed there has been a total of 3 reports, regarding 3 devices, for this device family and failure mode.During this same time frame 108 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 0.03.Per the instructions for use, the user is advised the following: 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 over pressurization at the operative site is to use direct pressure monitoring (via the cps tubing set).Please see section 18 for specific instructions on using the separate pressure sensing function.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

Update: further assessment was received on 21jun22.The procedure was a laparoscopic cholecystectomy.Both the surgeon and nurse are not convinced bradycardia was caused by the gs2000.This unit was replaced to eliminate one variable in the room.When the bradycardia was discovered insufflation was turned off, patient was given medication by anesthesia to increase heart rate, bolus of fluid given by anesthesia, patient was put head down.Approximately 10 minutes after the unit was first started is when the event occurred.General laparoscopic mode was selected.Smoke evacuation was not being used.Flow settings were 15 and 25 high flow.Conmed cautery was used and will be listed as a concomitant device.The sales representative reported on behalf of the customer that the device, gs2000, 50l abdominal insufflator was being used on 3jun22 and "patient experienced bradycardia¿.The procedure was completed with an alternate same device.There was a 2 minute delay.There was no impact or injury to the patient or user.The procedure was completed.Further assessment has been sent; however, to date no information has been obtained.This report is being raised on the basis of injury due to bradycardia.

• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 14752379
• MDR Text Key: 294644573
• Report Number: 1017294-2022-00072
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K120151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/10/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2022
• Initial Date FDA Received: 06/21/2022
• Supplement Dates Manufacturer Received: 08/03/2022
• Supplement Dates FDA Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONMED CAUTERY
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic