MAUDE Adverse Event Report: CONMED CORPORATION 50L ABDOMINAL INSUFFLATOR; INSUFFLATOR, LAPAROSCOPIC

Catalog Number GS2000

Device Problem Pressure Problem (3012)

Patient Problems Pulmonary Edema (2020); Abdominal Distention (2601)

Event Date 10/06/2016

Event Type  Injury  

Manufacturer Narrative

The 50l abdominal insufflator unit was returned to conmed for evaluation on 20-oct-2016.The unit has since been forwarded to the legal manufacturer for an in depth evaluation.As of this filing, the investigation remains in progress.A supplemental and final report will be filed upon the completion of the product evaluation and the complaint investigation.

Event Description

The user facility reported that during use of the 50l abdominal insufflator in a laparoscopic case, the unit would not regulate the pressure properly and did not alarm.As reported, the surgeon noted that intra-abdominal pressure was much higher and when attention was drawn to the unit, the pressure was noted and gas was flowing out of the tubing at a high rate, which allegedly over distended the abdomen and this required patient admission due to "non-cardiac pulmonary edema" after the surgery.A second insufflator unit was used to complete the case with no further complications or delay reported.Despite multiple attempts, to date, there has been no additional information received regarding the patient demographic information, patient's latest condition or any indication that a long term adverse effect has occurred.

Manufacturer Narrative

The legal manufacturer was notified and the device associated with this reported incident was returned to the physical manufacturer for evaluation.An evaluation and testing of the insufflator unit found the device software has a nonconformity, where the pressure calculation overflows resulting in a negative pressure when the actual pressure is in the range of 300 mmhg.Based on this evaluation finding, a supplier corrective action request (scar) was issued to the legal manufacturer to determine the root cause and to address this issue.This gs200 serial #(b)(4) was manufactured on 19-jun-2015 with no service repair history found.A 2-year review of complaints history shows no other similar reports of unit displayed incorrect pressure.There have been no patient long term adverse effects related to this type of reported incidents.The instruction manual (intended use) 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): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): NORTHGATE TECHNOLOGIES, INC.; 1591 scottsdale court; elgin IL 60123
• Manufacturer Contact: brenda johnson ; 11311 concept blvd.; largo, FL 33773 ; 7273995515
• MDR Report Key: 6062057
• MDR Text Key: 58604578
• Report Number: 1017294-2016-00115
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2016

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: Physician
• Device Catalogue Number: GS2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2016
• Initial Date FDA Received: 10/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2015
• 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): Hospitalization; Required Intervention; Disability