MAUDE Adverse Event Report: CONMED CORPORATION AIRSEAL IFS, 110V; INSUFFLATOR, LAPAROSCOPIC

Catalog Number AS-IFS1

Device Problems No Audible Alarm (1019); Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2016

Event Type  malfunction  

Manufacturer Narrative

The airseal ifs, 110v has been received for evaluation.As of this filing, the investigation remains in process.A supplemental and final medwatch report will be filed upon the completion of the investigation.

Event Description

The customer reported during a robotic prostatectomy using an airseal tri-lumen filtered tube set and an airseal ifs, 110v, the patient's abdomen was initially insufflated to a preset pressure of 15mmhg on high flow using a veress needle.While the staff waited for the attending surgeon to join the room, the airseal unit continued to flow co2 into the patient's abdomen until it reached over 50mmhg.The patient's blood pressure continued to rise until the anesthesiologist pointed out something was causing a rapid increase of the patient's blood pressure.The staff realized that the airseal unit was malfunctioning and removed the veress needle.No audible alarm was heard from the airseal unit.Co2 was removed from the patient's abdomen.A new airseal tri-lumen filtered tube set was used and the airseal ifs unit was restarted.This setup was used successfully to complete the rest of the surgery.There was no known patient injury and a 15-minute delay was reported.

Manufacturer Narrative

The used airseal ifs, 110v and airseal tri-lumen filtered tube set were returned for evaluation.Visual examination and functional testing determined there are no issues with the tubing set.The airseal ifs was inspected and tested.The unit passed visual inspection.Testing for boot up with high pressure bottle gas supply, over pressure response with venting valve and alarm responses, pressure defaults and flow defaults, insufflation mode testing, leakage testing and smoke evacuation testing all passed.The unit failed the system error(b5-85-7e-00)and the sensor response time tests.Engineering determined that neither of these two issues have any effect on the functionality of the airseal ifs and would not contribute to the alleged malfunction.A two-year review of complaint history shows that this is the only complaint received for this failure mode.The risk analysis was performed and the risk for the alleged pre-set pressure exceeded has been evaluated as acceptable.Based on the analysis of this device and investigation of the event, there is no evidence of a device malfunction.As reported, once initial insufflation had been achieved the unit was allowed to continue flowing co2 into the patients abdomen.The instructions for use provides the following warnings, precautions and instructions for use.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.Precautions: - the creation of pneumoperitoneum has know physiologic side effects, including decreased venous return, decreased cardiac output, reduced renal function, increased intracranial pressure, increased airway resistance, and reduced pulmonary compliance.Instructions for use - a single lumen, airseal veress needle adapter tube extension is attached to the tri-lumen tube set.- connect the veress needle adapter tube to the veress needle luer port and insert in accordance with proper laparoscopic technique.- push initial insufflation "start" on the airseal ifs touch screen, and initial insufflation will begin.- after initial insufflation has been achieved, detach the tri-lumen tue set from the veress needle tube extension.- remove the veress needle.

• Brand Name: AIRSEAL IFS, 110V
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): SEQUEL SPECIAL PRODUCTS; 122 avenue of industry; waterbury CT 06705
• Manufacturer Contact: brenda johnson ; 11311 concept boulevard; largo, FL 33773 ; 7273995515
• MDR Report Key: 6190332
• MDR Text Key: 62857556
• Report Number: 3006217371-2016-00041
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AS-IFS1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/31/2017
• 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
• Treatment: ASM-EVAC