MAUDE Adverse Event Report: WORLD OF MEDICINE AIRSEAL IFS, 110V; INSUFFLATOR, LAPAROSCOPIC

Catalog Number AS-IFS1

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

Patient Problem Pneumothorax (2012)

Event Date 03/01/2022

Event Type  Injury  

Event Description

Conmed japan reported on behalf of their customer that the device, as-ifs1, airseal ifs, 110v was being used on (b)(6) 2022 during a robotically-assisted gastrectomy procedure when it was reported ¿pneumothorax was confirmed after robot assisted gastrectomy.A few days later the patient was in remission.¿ the procedure was completed.After further assessment it was found that a chest tube was used to resolve the pneumothorax and it then remitted in a few days.The airseal did not alarm and it is not known what the settings were.There was no report of a delay and the patients current status and if there was any prolonged hospitalization is not known.This report is being raised on the basis of injury due to pneumothorax.

Manufacturer Narrative

Patients age was 80's.Manufacturer narrative: the device has not been returned to date and no photographic evidence was provided; therefore, a device malfunction cannot be verified.The service history was reviewed and no data was found.A device history record was requested from the supplier but to date has not been received.A two-year review of complaint history revealed there has been a total of 42 reports, regarding 42 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.02.Per the instructions for use, the user is advised the following: 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 and once a safe and proper entry has been achieved, ensure that the black line 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.

• Brand Name: AIRSEAL IFS, 110V
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): WORLD OF MEDICINE; salzufer 8; berlin 10587 ; GM 10587
• Manufacturer (Section G): WORLD OF MEDICINE; salzufer 8; berlin 10587 ; GM 10587
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 15129981
• MDR Text Key: 296871070
• Report Number: 1320894-2022-00166
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K190303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/29/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic