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

Catalog Number AS-IFS2

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

Patient Problems Air Embolism (1697); Stroke/CVA (1770); Convulsion/Seizure (4406)

Event Date 05/10/2021

Event Type  Death  

Manufacturer Narrative

Additional product code: gcj.Reported event is inconclusive.The device will not be returned for evaluation and no photographic evidence was provided; therefore, a root cause cannot be identified.If further information is obtained this report will be re-opened and reassessed.The service history was reviewed, and nothing was found.The supplier provided review of the device history review found no abnormalities that would contribute to this issue.(b)(4).Per the instructions for use, the user is advised the following: an authorized service technician has to inspect and service the device at appropriate intervals to ensure the safety and functionality of the unit.The minimum service interval is two years, depending on frequency and duration of use.If the service interval is not maintained, the manufacturer does not assume any liability for the functional safety of the device.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The distributor reported on behalf of the customer that the device, as-ifs2, airseal ifs, 230v was being used on (b)(6) 2021 during a laparoscopic liver resection procedure and ¿the patient could not wake up immediately post laparoscopic liver resection as he developed stroke from air embolism.The surgeon shares that for lap liver cases continuous suctioning is always on and always use 2 insufflators as he wants more co2 in hope to prevent entrapped room air - in this incidence, one airseal and another standard insufflator were used.It was reported that the procedure went smoothly with minimal bleeding and no alarms from airseal.¿ the procedure was completed.After further assessment it was found that on ¿(b)(6) 2021: patient noted to be persistently unresponsive in pacu despite reversal and administration of naloxone.Urgent ct brain and angiogram was conducted and pockets of gas seen on cta in the right cerebral hemisphere compatible with air embolism.Patient suffered seizures secondary to gas embolism.Terminally extubated on (b)(6) 2021 and demised on (b)(6) 2021.Cause of death reported to be cerebral gas embolism with cerebral infarction following laparoscopic liver wedge resection for hepatocellular carcinoma.¿ there was no delay to the procedure, according to surgeon, the surgery was smooth.This report is being raised on the basis of death due to cerebral gas embolism with cerebral infarction.

Manufacturer Narrative

Manufacturer narrative update: reported event of device creating a gas embolism is unconfirmed.The device was returned for evaluation.The device was found to be overdue for a preventive maintenance(pm), and likely damaged due to the bezel being cracked.The receiving socket for the tube was found to be worn.The oxygen sensor was found to have degraded and (b)(4) were out of specifications.This sensor should be replaced every 24 months as part of a pm.The software was found to be not the newest version, but current for the reported issue of this complaint, version 1.8.4.0 dealt with overpressure issues.No electronic error codes were found.A two-year review of complaint history revealed there has been a total of (b)(4) reports, regarding (b)(4) 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 (b)(4).This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The distributor reported on behalf of the customer that the device, as-ifs2, airseal ifs, 230v was being used on (b)(6) 2021 during a laparoscopic liver resection procedure and ¿the patient could not wake up immediately post laparoscopic liver resection as he developed stroke from air embolism.The surgeon shares that for lap liver cases continuous suctioning is always on and always use 2 insufflators as he wants more co2 in hope to prevent entrapped room air - in this incidence, one airseal and another standard insufflator were used.It was reported that the procedure went smoothly with minimal bleeding and no alarms from airseal.¿ the procedure was completed.After further assessment it was found that on ¿(b)(6) 2021: patient noted to be persistently unresponsive in pacu despite reversal and administration of naloxone.Urgent ct brain and angiogram was conducted and pockets of gas seen on cta in the right cerebral hemisphere compatible with air embolism.Patient suffered seizures secondary to gas embolism.Terminally extubated on (b)(6) 2021 and demised on (b)(6) 2021.Cause of death reported to be cerebral gas embolism with cerebral infarction following laparoscopic liver wedge resection for hepatocellular carcinoma.¿ there was no delay to the procedure, according to surgeon, the surgery was smooth.This report is being raised on the basis of death due to cerebral gas embolism with cerebral infarction.

• Brand Name: AIRSEAL IFS, 230V
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 13548828
• MDR Text Key: 285744362
• Report Number: 1320894-2022-00039
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K190303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/12/2022

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-IFS2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2022
• Initial Date FDA Received: 02/17/2022
• Supplement Dates Manufacturer Received: 05/10/2022
• Supplement Dates FDA Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Death; Required Intervention; Hospitalization
• Patient Ethnicity: Non Hispanic