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

Catalog Number AS-IFS1

Device Problem Inflation Problem (1310)

Patient Problem Swelling (2091)

Event Date 05/27/2019

Event Type  Injury  

Manufacturer Narrative

Complaint is inconclusive.The device is not being returned and no photograph evidence was provided.Therefore, the reported failure could not be verified.The service history was reviewed and no data was found.The device history record was not reviewed, as the device is not manufactured by conmed.A two-year review of complaint history revealed there has been 4 complaints regarding (b)(4) devices for this device family and failure mode.During the same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following; to use extreme caution during airseal access port insertion.Improper use of this product can result in life-threatening injury to internal organs and vessels.Ensure that adequate pneumoperitoneum or pneumorectum is established.Ensure that the patient is properly positioned so that organs are away from the penetration site.Direct the airseal access port's tip away from significant vessels and organs.Do not use excessive downward force.Once a safe and proper entry has been achieved, ensure that the black like at the distal tip of the airseal access port is visible within the cavity at all times the airseal access port is being used for insufflation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The conmed representative reported on behalf of the facility that the as-ifs1, airseal unit, caused subcutaneous emphysema after a laparoscopic nissen.The subcutaneous emphysema resolved post-surgery 24-48 hours later.This report is being raised due to patient injury.

• Brand Name: AIRSEAL IFS 110V
• Type of Device: INSUFFLATION GENERATOR
• Manufacturer (Section D): W.O.M WORLD OF MEDICINE GMBH; salzufer 8; 4th floor; berlin, 10587 ; GM 10587
• Manufacturer (Section G): W.O.M WORLD OF MEDICINE GMBH; salzufer 8; 4th floor; berlin, 10587 ; GM 10587
• Manufacturer Contact: melanie lannon ; 11311 concept boulevard; largo, FL 33773 ; 7273995209
• MDR Report Key: 8802159
• MDR Text Key: 151422183
• Report Number: 3006217371-2019-00230
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K172516
• 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
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AS-IFS1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR