MAUDE Adverse Event Report: CONMED CORPORATION AIRSEAL IFS, 230V; INSUFFLATOR, LAPAROSCOPIC

Catalog Number AS-IFS2

Device Problem Insufficient Information (3190)

Patient Problem Swelling (2091)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

The airseal unit was returned to conmed service center in (b)(4) for evaluation on 08-jul-2016.A preliminary evaluation, including electrical safety test, basic function test, pressure sensor test, pressure monitoring test, maximum pressure test, and gas flow rate test found no fault.The device was found within specification for all tests.The device is now pending a determination by the manufacturer if additional testing is required.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 a tatme rectal cancer surgery on (b)(6) 2016, insufflation could not be achieved at the rectal end.The surgeon concluded it could be due to patient factors (tumour causing bowel closure) and converted to open surgery.The procedure was otherwise completed with no patient injury and approximately 30-minutes delay.To date, other than a report of the conversion to an open procedure, there has been no additional information received regarding the patient's latest condition or any indication that a long term adverse effect has occurred.

Manufacturer Narrative

For thoroughness, the airseal unit was returned to the legal manufacturer for additional evaluation and testing.Received information confirmed that the returned unit performed as intended and passed all functional test requirements with no errors or issues observed.In this instance, it is believed the most probable cause of this reported problem was due to a procedural technique issue.A review of the adverse event history for this device shows this is an isolated incident.The reported problem will continue to be monitored via the complaint system to ensure product safety.No further action is planned at this time.This failure mode is addressed in the dfmea, and the safety risk has been found to be acceptable.The airseal® ifs system is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments and to evacuate surgical smoke.It is indicated to facilitate the use of various laparoscopic instruments by filling the abdominal cavity with gas to distend it by creating and maintaining a gas sealed, obstruction free path and by evacuating surgical smoke.To reduce the risk of patient injury, the as-ifs instructions for use (ifu) provides the following warnings: · failure to properly follow the instructions for use can lead to serious surgical consequences.· only qualified physicians with knowledge, experience and training in laparoscopic techniques should use the components of the airseal access system.· these instructions for use do not include descriptions or instructions for surgical techniques or laparoscopic procedures.It is the responsibility of the physician performing any procedure to determine the appropriateness of the type of procedure to be performed with the use of these products and to determine the specific technique for each patient.

• Brand Name: AIRSEAL IFS, 230V
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): SURGIQUEST, INC.; 488 wheelers farms road; milford CT 06461
• Manufacturer Contact: brenda johnson ; 11311 concept blvd.; largo, FL 33773 ; 7273995515
• MDR Report Key: 5820234
• MDR Text Key: 50353988
• Report Number: 3006217371-2016-00022
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K143404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/30/2016

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: Health Professional
• Device Catalogue Number: AS-IFS2
• Device Lot Number: 1509CE0822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2016
• Initial Date FDA Received: 07/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention