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

Catalog Number GS2000

Device Problems No Audible Alarm (1019); Gas Output Problem (1266)

Patient Problem Swelling/ Edema (4577)

Event Date 05/04/2021

Event Type  Injury  

Manufacturer Narrative

Reported event is unconfirmed.Customer event ¿insufflator pressure was turned up to 25 vs.The max of 15.Patient had extremely high co2 levels and was swollen from head to toe¿ was not confirmed during the evaluation process.The device was received in largo, and the inspection did not reveal any abnormalities.The service history was reviewed and no previous relationship to this complaint was found.A device history review was requested from the manufacturer, and no indication of abnormalities was communicated.A two-year review of complaint history revealed there has been a total of two complaints, regarding two devices, 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 0.01.Per the instructions for use, the user is advised the following: 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).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

The sales representative reported on behalf of the customer that the device, gs2000, was being used on (b)(6) 2021 during a laparoscopic bowel resection procedure and the ¿insufflator pressure was turned up to 25 vs.The max of 15.Patient had extremely high co2 levels and was swollen from head to toe.His face and neck were dangerously swollen and he was sent to the icu.He was still intubated 6 hours after surgery was completed.¿ after further assessment, it was found this event occurred about 30 minutes after the unit was started.There were no audible alarms, the yellow bell icon and flow restriction did not appear on the screen.The gs1016 pressure sense tubing was connected to a trocar and will be listed as a concomitant device.The actual pressure display was not flashing and was the normal colors.No indication that there was a problem.Flow setting was verres and max flow.A cylinder of the regular size that fits onto the conmed tower was used.Smoke evacuation was not used.The camera was in the trocar during insufflation.General laparoscopic operating mode was selected.Started the case using a verres, the surgeon had a difficult time gaining access into the abdominal space.The surgeon was adjusting the camera and scope and contaminated the light source.The team was scrambling to get another light source and light cable.Replaced the light source and the surgeon proceeded with the case.After about 30 minutes, anesthesia mentioned to the surgeon the patient co2 levels were extremely high.This is when the surgeon noticed the consul pressure setting was at 25 mmhg.The pressure was lowered to 15 mmhg.The surgery was resumed as planned.After the surgery, they left the patient intubated and transferred him to the icu where he was left intubated for approximately six hours.The roughly (b)(6) pound patient is doing good.This report is being raised on the basis of injury due to sub-q emphysema and prolonged hospitalization.

• Brand Name: 50L ABDOMINAL INSUFFLATOR
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): NORTHGATE TECHNOLOGIES; 1591 scottsdale court; elgin IL 60123
• Manufacturer (Section G): NORTHGATE TECHNOLOGIES; 1591 scottsdale court; elgin IL 60123
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 12407894
• MDR Text Key: 274800509
• Report Number: 1017294-2021-00330
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• 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: 06/24/2021
• Date Manufacturer Received: 05/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization