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 05/23/2019

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.(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 pneumomediastinum after a laparoscopic bowel/ sigmoid resection.The air was noticed after a routine post op chest x-ray was done.The patient is to return for a secondary x-ray to see if the issue was resolved.To date there is no information on the patient status.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: 8802157
• MDR Text Key: 151422450
• Report Number: 3006217371-2019-00231
• 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

• 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
• Initial Date Manufacturer Received: 06/19/2019
• Initial Date FDA Received: 07/18/2019
• 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
• Treatment: ASM-EVAC 1 TUBING SETIAS12-100PI TROCAR
• Patient Outcome(s): Other
• Patient Age: 66 YR