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

Catalog Number GS2000

Device Problems No Audible Alarm (1019); Alarm Not Visible (1022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/07/2017

Event Type  malfunction  

Manufacturer Narrative

The product has not yet been returned for evaluation.When the device is returned, conmed will perform an evaluation and upon completion will file a supplemental medwatch report.

Event Description

It was reported by the user facility that during a robot assisted laparoscopy the surgeon seated the primary robot port (camera port) by hasson technique and connected the gas warmer cable as per routine.The procedure was started using a gs1016 insufflation tubing set with filter.The 50l abdominal insufflator was preset to 12mmhg at a flow speed of 45 liters/minute.The abdominal organs were visually inspected.As the assisting surgeon palpated the abdomen, the abdomen was noted to be hard like a board and simultaneously it was observed that the intra-abdominal pressure was 50mmhg.It was reported that no alarm activated and the electronic safety valve did not relieve the over pressure.The assisting surgeon immediately closed the gas port valve and opened the camera port to evacuate the intra-abdominal gas.The anesthetic nurse advised that the patient was circulatory and respiratory stable.The surgeon considered converting to open surgery but then decided to try again using the same gs2000 unit and gs1016 tubing set.This time a cps tubing (used to measure intra-abdominal pressure with separate sensing line) was also used.The pressure setting was decreased and set to 10mmhg and the flow rate set at 25 liters/min.The anterior resection was performed while the intra-abdominal pressure was continuously monitored.The system worked normally and the procedure was completed without any further problems.The user facility reports that the patient was not harmed and only a 5-minute surgical delay occurred.

Manufacturer Narrative

The legal manufacturer (b)(4) has been notified of this reported incident.This insufflator was not returned to the manufacturer for an analysis.The contact in (b)(6) provided a tracking number and erroneously indicated it was for this device.It has since been determined that the tracking information was for a device that is unrelated to this report.This insufflator was analyzed at customer's facility.The conmed product manager has advised that the gs2000 insufflator, s/n (b)(4) belongs to conmed (b)(4).It was being loaned to the customer at the time this issue was reported.The product manager reports he has visited the facility and has carefully checked the operation of this unit while it was being used in surgeries.There were no problems identified with the performance and no issues experienced with the alarms or valves.The product manager reports that the customer has reported similar complaints with their own unit.When their unit was returned for evaluation and testing, the manufacturer found that the unit passed all functional testing requirements and performed within design specifications with no abnormalities or problems noted.Based on the customer's reports of identical issue and the same results of device analysis; no device problem, the likely root cause of this alleged incident is related to a use/handling related issue.Since this incident report, product training has been provided to this customer.This gs2000 serial #(b)(4) was manufactured in may-2014 with no prior records showing service or repair.A 2-year review of device complaint history shows a total of 6 similar reportable events including this one.Four (4) of these events were received from this same user facility.To date, there have been no patient long term adverse effects reported resulting from this type of incident.The instruction manual states: the gs1000 and gs2000 series of insufflators shall be used for gas distension of the abdomen for diagnostic and/or operative laparoscopy.They should be used only when laparoscopic procedures are called for, and should therefore not be used for any other treatments.The conmed¿ gs2000 insufflator should be used only when minimally invasive procedures are called for, and should therefore not be used for any other treatments.It is designed to function with specific minimally invasive instruments that provide passage of gas to specific body cavities and should only be used with instruments specifically designed for that purpose.It should only be used under the direct guidance of a surgeon skilled in laparoscopic and minimally invasive surgical procedures.To reduce the risk of patient injury the instruction for use (ifu) provides the following precautions and warnings: prolonged intra-abdominal pressures greater than 20 mmhg should be avoided.This can cause any of the following: metabolic acidosis with resultant cardiac irregularity.Compromised diaphragmatic excursion resulting in decreased respiration.Decreased venous return.Decreased cardiac output.Excessive absorption of co2 results from either excessive flow rate and/or excessive pressure.The abdomen can be adequately distended by pressure in the range of 15-20 mmhg.Use of pressure <20 mmhg will dramatically reduce the likelihood of intravasation of co2 gas into open vascular channels.Also, adequate respiration helps avoid problems related to excessive or retained co2.Infusion of co2 can result in carbonic acid irritation of the diaphragm.This device should be operated only by or under the direct supervision of a physician experienced in laparoscopic / endoscopic surgical procedures.The user should be thoroughly familiar with the operation of this device prior to use.Infusion of co2 can result in embolization.Improper placement of the insufflation instrument could cause insufflation of gas into a vessel, resulting in air or co2 embolisms.To reduce the risk of air or co2 embolism, perform initial insufflation at a low flow rate and ensure that the insufflation instrument is correctly positioned.Check the position of the insufflation instrument immediately if the actual pressure rapidly reaches the nominal pressure value.Co2 embolisms can also be caused by a high intra-abdominal pressure.Avoid high-pressure setting and close damaged vessels at once.

• 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: brenda johnson ; 11311 concept boulevard; largo, FL 33773 ; 7273995515
• MDR Report Key: 6366000
• MDR Text Key: 68602906
• Report Number: 1017294-2017-00017
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K022052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/21/2017

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 Operator: Physician
• Device Catalogue Number: GS2000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2017
• Initial Date FDA Received: 02/28/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: CPS TUBING SET; GS1016 INSUFFLATION TUBING SET WITH FILTER