MAUDE Adverse Event Report: CONMED / LINVATEC AIRSEAL

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pneumothorax (2012); Respiratory Distress (2045)

Event Date 12/19/2017

Event Type  Injury  

Event Description

This is to report suspected entrainment of atmosphere in lieu of carbon dioxide in conmed's airseal medical device.The pt is a (b)(6) y/o man who underwent an elective laparoscopic paraesophageal hiatal hernia repair.The abdomen was insufflated using conmed airseal system.This system "purports" to deliver 100% carbon dioxide in order to achieve pneumoperitoneum.During the operation, the pleural space was entered bilaterally.This occurs commonly during the dissection for this procedure.Typically, the capnothorax bilaterally that results from entering the pleural space resorbs very quickly, and is typically gone within an hour.We know this because we typically will obtain a chest x-ray in the recovery room.It typically shows complete resolution of the capnothorax.The absorption of co2 from the pleural space is so reliably quick that most surgeons won't place a chest tube to evacuate the capnothorax - it is not necessary.In this case, using conmed's airseal, the pt had a persistent pneumothorax bilaterally.He was short of breath.He had a 40% pneumothorax on the right and a 20% pneumothorax, on the left.We hospitalized him for several extra days, obtaining chest x-rays on the first, second, and third postoperative day.All showed persistent pneumothorax.Such persistence can only be the result of significant entrainment of atmospheric gas into airseal's trocar.In other words, the device is suspected of not delivering 100% carbon dioxide.It must have entrained some atmosphere.The atmosphere's nitrogen content.(70% of atmosphere is nitrogen) is poorly soluble into human tissues, and explains the persistent pneumothorax.

• Brand Name: AIRSEAL
• Type of Device: AIRSEAL
• Manufacturer (Section D): CONMED / LINVATEC; utica CA 13502
• MDR Report Key: 7209042
• MDR Text Key: 97983259
• Report Number: MW5074691
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/17/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 61 YR
• Patient Weight: 80