MAUDE Adverse Event Report: W O M WORLD OF MEDICINE GMBH AIRSEAL IFS, 230V; INSUFFLATOR, LAPAROSCOPIC

Catalog Number	AS-IFS2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	10/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported on behalf of their customer that the as-ifs2, airseal ifs, 230v was being used during a laparoscopic oncologic procedure on (b)(6) 2023, when it was reported ¿during veress needle insufflation the patient got a ventricular fibrillation and cardiac arrest, reanimation was necessary.The heard ultrasound show air in the heart ventricles.Procedure was interrupted.¿ it was also reported ¿procedure was interrupted and patient was transferred to the intensive care.The patient will be managed in intensive care.¿ an alternate device was not used to complete the procedure.This report is being raised on the reported injury due patient obtaining ventricular fibrillation and cardiac arrest leading to treatment in the intensive care unit.
Event or Problem Description
The distributor reported on behalf of their customer that the as-ifs2, airseal ifs, 230v was being used during a laparoscopic oncologic procedure on (b)(6) 2023 when it was reported ¿during veress needle insufflation the patient got a ventricular fibrillation and cardiac arrest, reanimation was necessary.The heard ultrasound show air in the heart ventricles.Procedure was interrupted.¿.It was also reported ¿procedure was interrupted and patient was transferred to the intensive care.The patient will be managed in intensive care.¿.An alternate device was not used to complete the procedure.This report is being raised on the reported injury due patient obtaining ventricular fibrillation and cardiac arrest leading to treatment in the intensive care unit.
Additional Manufacturer Narrative
The device will not be returned, 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 review was not conducted as the device has been in the field for greater than 12 months a two-year review of complaint history revealed there has been a total of 4 complaints, regarding 4 devices, for this device family and failure mode.During this same time frame (b)(4) have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, (b)(4).Per the instructions for use, the user is advised that the service and maintenance of the device and its accessories has to be carried out as per instructions to ensure the safe operation of the device.For the protection of the patient and the operating team, check that the device is properly connected and functional.The insufflation of co2 should be done carefully and while monitoring the patient¿s response.The user, particularly the anesthetist, should be informed about possible cardiovascular and respiratory problems of the patient and monitor these intra-operatively.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: AIRSEAL IFS, 230V
• Common Device Name: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): W O M WORLD OF MEDICINE GMBH; salzufer 8; berlin 10587 ; GM 10587
• Manufacturer (Section G): W O M WORLD OF MEDICINE GMBH; salzufer 8; berlin 10587 ; GM 10587
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 18057036
• Report Number: 1320894-2023-00240
• Device Sequence Number: 17620661
• Product Code: HIF
• UDI-Device Identifier: 10851885004594
• UDI-Public: 011085188500459411180906
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K190303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: AS-IFS2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic