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

Model Number GS2000

Device Problem Inaccurate Flow Rate (1249)

Patient Problem Pulmonary Emphysema (1832)

Event Date 10/20/2022

Event Type  Injury  

Event Description

The distributor reported on behalf of their customer that the gs2000, 50l abdominal insufflator, was being used during a laparoscopic cholecystectomy procedure on (b)(6) 2022 when it was reported, ¿the equipment has a fault with the pressures and flows showing values that do not correspond and high insufflation flows presenting several cases of intra-abdominal hypertension with hemodynamic change in patients.With the increase in co2, patients have developed emphysema, severe hypercapnia.The flow rate established in the equipment is 30 l/min., the equipment does not alarm despite the fact that the delivery of this flow is greater, it presents pressure regulation failure.¿ further assessment questioning found that the procedure was completed, with the use of an alternate device and a 40-minute delay.The patient status was reported as ¿hospitalized in intensive care unit.¿ there was no report of surgical intervention for the patient.This report is being raised on the basis of injury due to patient developing emphysema and hypercapnia which let to extended hospitalization in the intensive care unit.

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.Device not yet received.

Manufacturer Narrative

Reported event, ¿pressure regulation failure,¿ is unconfirmed based on device evaluation.Evaluation of the device could not confirm the reported event.A dhr was requested from the manufacturer; however, has not been provided to date.The service history was reviewed, and no prior relationship to this complaint was found.A risk analysis cannot be conducted since conmed does not own the risk documents for this device.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The distributor reported on behalf of their customer that the gs2000, 50l abdominal insufflator, was being used during a laparoscopic cholecystectomy procedure on (b)(6) 2022 when it was reported, ¿the equipment has a fault with the pressures and flows showing values that do not correspond and high insufflation flows presenting several cases of intra-abdominal hypertension with hemodynamic change in patients.With the increase in co2, patients have developed emphysema, severe hypercapnia.The flow rate established in the equipment is 30 l/min., the equipment does not alarm despite the fact that the delivery of this flow is greater, it presents pressure regulation failure.¿ further assessment questioning found that the procedure was completed, with the use of an alternate device and a 40-minute delay.The patient status was reported as ¿hospitalized in intensive care unit.¿ there was no report of surgical intervention for the patient.This report is being raised on the basis of injury due to patient developing emphysema and hypercapnia which let to extended hospitalization in the intensive care unit.

Manufacturer Narrative

Update: per our vendor evaluation, no further information was received from the end user on the event and the conditions present during the complaint event is unknown, despite multiple attempts.Capa ((b)(4)) was initiated to investigate the complaint with available information.The complaint could not be verified and no issues in device performance were noted during engineering evaluation.The device performed as expected when an overpressure condition was induced and the device did not exceed the pressure limit to produce a overpressure condition.The device was moved to service after engineering evaluation for recalibration.The device was tested under the complaint condition at 30lpm with 30mmhg gas pressure.The device performed as expected.The safety relief valves in the device were performing as expected.The flow at 1 lpm was noted to be unstable and the 50lpm flow was below specification.The low flow being unstable was traced to the low/medium manifold sapphire orifice to be damaged within the manifold.The low and medium flow rates are only controlled by low flow manifold and the sapphire orifice is only present on low flow end (0-5lpm), hence this damage would not impact the flow or pressure control during use of the device at 30 lpm as indicated in the complaint information.The low flow manifold was replaced and unit was recalibrated.The device passed all fqc testing and inspection.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.We will continue to monitor for trends through the complaint system to assure patient safety.

• 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 15798129
• MDR Text Key: 303650159
• Report Number: 1017294-2022-00108
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 20845854045395
• UDI-Public: 20845854045395
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: D161484
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GS2000
• Device Catalogue Number: GS2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COVIDIEN PNEUMOINFLATOR.; COVIDIEN PNEUMOINFLATOR.
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic