MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH AIRSEAL IFS, 110V; AIRSEAL CAPITAL

Catalog Number AS-IFS1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pneumothorax (2012)

Event Date 12/19/2017

Event Type  Injury  

Manufacturer Narrative

The device has been returned to conmed for evaluation.A complaint evaluation is underway, a supplemental report will be filed following it's completion.

Event Description

The user facility reported that post robotic assisted hiatal hernia surgery with the use of as-ifs1, with a set pressure of 15mmhg and approximately 30 minutes at 10mmhg, the patient suffered from bi-lateral pneumothorax.This led to a 2-day prolonged hospital stay and supplemental oxygen therapy.Upon gathering additional information from the surgeon, the patient was discharged home and the pneumothorax resolved in 2 weeks.This report is raised on the basis of a reported patient injury.

Manufacturer Narrative

The reported device was returned to conmed for evaluation.Functional testing was performed by way of running the unit for over thirty minutes in airseal mode at 15mmhg.The unit met specifications and performed as intended.The information obtained does not reasonably suggest that the device has or may have caused or contributed to a death, serious injury or has malfunctioned in a manner that would be likely to cause or contribute to injury if it were to recur.Based on the serial number, this device was manufactured in 2016.A service history was conducted and this device has no record of being serviced; preventative maintenance is recommended every two years.A two-year review of complaint history revealed no prior similar complaints for this product family.The instructions for use advise the user of the following.Failure to properly follow the instruction 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.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: AIRSEAL IFS, 110V
• Type of Device: AIRSEAL CAPITAL
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 7277114
• MDR Text Key: 100278491
• Report Number: 3006217371-2018-00040
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K143404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: AS-IFS1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 61 YR
• Patient Weight: 80