MAUDE Adverse Event Report: NORTHGATE TECHNOLOGIES INC. SMITH & NEPHEW INSUFFLATOR 500; INSUFFLATOR, LAPAROSCOPIC, 50LPM

Model Number 72-00259-0

Device Problem Increase in Pressure (1491)

Patient Problem Cardiovascular Insufficiency (4445)

Event Date 02/03/2021

Event Type  Injury  

Manufacturer Narrative

The insufflator, nti part number 72-00259-0; serial number (b)(4) has not arrived at nti as of this report 7/21/2021 from the distributor smith & nephew, inc.The device and complaint will be evaluated under capa (b)(4).The device is expected to be returned to nti for investigation and the investigation will commence once the unit has been received at nti, any additional findings will be updated via a follow-up report.Numerous attempts have been made to gather additional information regarding the patient outcome, event details, and/or device information from the distributor however no further information has been provided at this time therefore this report is being filed with the information provided.The device history record for (b)(4) from november of 2017.((b)(4)) 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.The (b)(4) risk analysis was reviewed.Section 7.1.10.1 d refers to the risk of pressure in general laparoscopic mode with hazard of metabolic and cardiac reaction.Reduced respiration with restricted diaphragm function.Reduction of venous reflux and reduced cardiac output.There are warnings in the manual that indicate: the dangers of co2 absorption, embolism, idiosyncratic reactions, metabolic and cardiac reactions; the danger of subcutaneous emphysema; and the use of additional insufflation sources increases the intra-abdominal pressure and requires continuous monitoring for the entire procedure.Mitigation of the risk is.Additional device mitigations: the overshoot is limited to fda recommendation not to exceed 45 mmhg for more than 15 seconds; the overpressure alert will activate at 5 mmhg over the preset and a lapse of less than or equal to 5 seconds; temporary disabling of the overpressure alert will not exceed 30 seconds; multiple failures in the unit are required to cause overpressure of the abdominal cavity; and visual and audible indicators are on the machine to indicate volume of gas remaining in cylinder.The severity of the risk is 5 (potential death) with likelihood of 2 (remote).A clinical evaluation was performed under (b)(4) which indicated the benefits outweigh the risks.Section 7.6.4 refers to the risks of loss of mechanical integrity with the risk of unit not being able to maintain pneumoperitoneum resulting in delay of surgery.Mitigation of the risk the fmea was developed to identify any risks due to failure.Caution is in manual recommending yearly maintenance and calibration of the unit.The severity of the risk is a 3 (injury but no permanent impairment, intervention required) with likelihood of 2 (unlikely to happen).A clinical evaluation was performed under nor-(b)(4) which indicated the benefits outweigh the risks.A 4-year review of complaints history shows no other similar reports of "heart attack".Other than this reported incident, there has been 3 other adverse event received related to the use of this device or similar devices in the past four years.The instruction manual (intended use) states: the smith & nephew 500 insufflator provides co2 gas distention of surgical cavities for diagnostic and/or operative endoscopy.The smith & nephew 500 insufflator is indicated for use as a means of providing co2 for cavity distension during minimally invasive surgical procedures.They should be used only when laparoscopic procedures are called for, and should therefore not be used for any other treatments.The 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.A distending pneumoperitoneum is contraindicated in patients unable to tolerate either decreased venous return or increased paco2's.To reduce the risk of patient injury the manual provides the following precautions and warnings: prolonged intraabdominal 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.Idiosyncratic reactions: in patients with sickle cell disease or pulmonary insufficiency, use of these devices may pose increased risks of metabolic imbalance related to excessive co2 absorption.

Event Description

On 6/22/2021 northgate technologies was made aware of the following alleged event with a smith & nephew insufflator, " it was reported that during a surgery the insufflator pressure requested was 15mm hg but the flow became free and rose to 19mm hg and was increasing, the insufflator was turned off by the nurse.The patient had a heart attack during the procedure.It is unknown if there was an available back up device or a significant delay during the procedure.No patient injury or other complications were reported." no further information has been received by the manufacturer despite multiple attempts to obtain further information.

Manufacturer Narrative

H10: addition: the device was evaluated under capa 21034.· unit was found to have a cracked touch screen and did not respond to touch.However, the unit did power up normally.The lower left front corner has a crack.The damage was likely caused by inadequate packing and dropping during shipping.After the touch screen was replaced, the unit displayed a fault code 4 (fc4) on power up.Fc4 could not be resolved without having both the display board and valve control board replaced.This could be due to some latent damages in the unit that surfaced during the disassembling of the display assembly when replacing the touch screen.Since the unit could not be powered up normally with the original boards in its as-received state, further troubleshooting was needed to resolve the fc4 issue.After some initial troubleshooting, a suspected microprocessor was replaced on the valve board.The repaired valve board was reassembled into the unit and reprogrammed with the current software.The unit powered up normally with the repaired valve board and the device was re-calibrated since all calibration data was lost when the microprocessor was replaced.This confirms that the fc4 was due to the defective microprocessor.The device fault code history also recorded over 82 fc4's, further indicating the issue has occurred for some time.The device manual indicates that the device should be sent in for annual calibration / preventive maintenance.This device has never been sent in for calibration nor maintenance.With the device now restored to a working condition, albeit not in its original state, it functions as expected.Attempts were then made to reproduce an over-pressure situation using a simulator bag with both the main tubing and tap tubing connected.These included applying pressure to the simulator bag, kinking of the tubing, partial blockage to the flow.In all cases the device either sounded an alert and relieved the excess pressure or indicated a restriction condition (all of which is expected behavior).However, extended over-pressure conditions could not and cannot be reproduced.Both the mechanical prv and electronic prv's were tested and functioned as expected.· in summary, the device in its as found state exhibited a fault code 4 (caused by an internal communication error), primarily due to a defective pin on the valve board microprocessor.The device itself, however, would still perform to specification even if the fc4 can be cleared by power cycling (although this is possible, it was not possible for the device as returned to the manufacturer).The increase in pressure from the 15 mmhg set pressure to 19 mmhg as reported was not likely caused by the defective pin in the microprocessor.A temporary increase in pressure during normal operation can occur in the event of a flow restriction or if a suction device used in the proximity of the tap tubing trocar.The device is designed to vent excessive pressure through the electronic prv's to within 5 mmhg in 5 seconds when the measured pressure exceed 5 mmhg from the set pressure or through the mechanical prv when the pressure exceeds 45 mmhg.Pressure overshoots are limited to fda recommendations not to exceed 45 mmhg for more than 15 seconds; the overpressure alert will activate at 5 mmhg over the preset and a lapse of less than or equal to 5 seconds; and temporary disabling of the overpressure alert will not exceed 30 seconds.All design mitigations were operating in the device according to specification after the device was modified to address the fault code 4.

• Brand Name: SMITH & NEPHEW INSUFFLATOR 500
• Type of Device: INSUFFLATOR, LAPAROSCOPIC, 50LPM
• 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 ; 2248562250
• MDR Report Key: 12207811
• MDR Text Key: 281991422
• Report Number: 0001450997-2021-00003
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 00817183020677
• UDI-Public: 00817183020677
• 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,Distributor
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72-00259-0
• Device Catalogue Number: 72203994
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2017
• 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
• Patient Outcome(s): Other