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

Catalog Number GS2000

Device Problems Failure to Auto Stop (2938); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Distention (2601); No Known Impact Or Consequence To Patient (2692)

Event Date 12/16/2016

Event Type  Injury  

Manufacturer Narrative

As of this filing, the 50 l abdominal insufflator unit has not yet been returned from the user facility for evaluation.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 the surgeon experienced problems with the use of the gs2000 the 50 l abdominal insufflator, in that the patient "abdomen was blown up to a much higher pressure than the set point and the insufflator did not stop the insufflation".The report further stated that "at the surgery on (b)(6) 2016 and after three (3) attempts on the patient, the robot assisted laparoscopy procedure was cancelled because of the elevated co2 levels in the patient".Despite multiple attempts, to date there has been no additional information received regarding the patient demographic information, the surgery rescheduling and the 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 received by the physical manufacturer for evaluation on 23-feb-2017.A thorough evaluation and testing of the insufflator using internal test methods was performed and found that the unit passed all functional testing requirements and performed within design specifications with no abnormalities or problems noted that could have caused or contributed to the alleged incident.Based on this finding, the complaint could not be verified and the root cause of this reported incident therefore could not be determined.This gs2000 serial #(b)(4) was manufactured on 09-oct-2014 with the last service repair date of (b)(6) 2016 with no problems noted.A 2-year review of the device complaint history shows a total of 10 reports received with similar problem including this one, of which 4 were received from the same user facility.Of the 10 complaints received, only 6 were considered as reportable events.To date, there have been no patient long term adverse effects reported resulting from this type of 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.Follow-up with the affiliate revealed that although the complaint was generated on 18-jan-2017, the awareness date remained on (b)(6) 2016 when the complaint was first reported to the international affiliate in (b)(6).What delayed the complaint submission to conmed usa was due to the gathering of data (incident description, etc.) from the user facility to generate the complaint.

• 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 scottdale court; elgin IL 60123
• Manufacturer Contact: brenda johnson ; 11311 concept boulevard; largo, FL 33773 ; 7273995515
• MDR Report Key: 6282597
• MDR Text Key: 65941393
• Report Number: 1017294-2017-00006
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 10653405002017
• UDI-Public: (01)10653405002017(17)210815(30)1(10)201608161
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2017

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: Health Professional
• Device Catalogue Number: GS2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/18/2017
• Initial Date FDA Received: 01/27/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2014
• 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): Life Threatening; Required Intervention; Disability