MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH AIRSEAL IFS, 110V; INSUFFLATOR, LAPAROSCOPIC

Catalog Number AS-IFS1

Device Problem No Apparent Adverse Event (3189)

Patient Problem Embolism/Embolus (4438)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

Is an approximate date.The exact date of the event is not know.Secondary fda product code is gcj.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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the as-ifs1 was being used during a robotic hepatic resection on approximately (b)(6) 2020 when it was reported "dr.(b)(6) mentioned that he likes airseal, but that he had a couple patients who had become unstable during robotic hepatic resection procedures.He believes that an embolism occurred and asked if the airseal brings in room air.He is concerned about any embolism that contained air rather than c02.I explained that during prolonged suction, the airseal may bring in room air to help maintain pnuemo and that after the suctioning the airseal processes to return the gas mixture to being mostly co2.He said the patient's issues resolved themselves eventually, and they are fine.However, they now they are taking some precautions (anesthesia puts tee ultrasound probe for the case down the esophagus to look for bubbles in the heart; and blood pressure checked very frequently)." there was no report of injury, medical intervention, or hospitalization for the patient.Further assessment information was requested for possible other accounts of this type and no further response has been received to date.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device will not be returned for evaluation and no photographic evidence has been provided; therefore, the reported event cannot be verified.The manufacturing documents from the device history record have not been reviewed because the serial number of the device is not available.The service history review was not conducted because the serial number of the device is not available.A two-year review of complaint history revealed there has been a total of 234 complaints, regarding 234 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).Per the instructions for use, 10000010595, the user is advised that improper placement of the insufflation instrument could cause gas penetrating a vessel or an internal organ, resulting in gas embolism.To reduce the risk, use a low flow rate for the first insufflation and ensure that the insufflation instrument is correctly positioned.Check the position of the insufflation instrument immediately if the actual pressure rapidly reaches the nominal pressure value, gas embolisms can also be caused by a high intra-abdominal pressure.Avoid high-pressure settings and close damaged blood vessels at once.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): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; 4th floor; berlin 10587 ; GM 10587
• MDR Report Key: 10884574
• MDR Text Key: 217943798
• Report Number: 1320894-2020-00524
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K143404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AS-IFS1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 11/23/2020
• Supplement Dates Manufacturer Received: 12/10/2020
• Supplement Dates FDA Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1