MAUDE Adverse Event Report: W.O.M WORLD OF MEDICINE GMBH AIRSEAL IFS 110V; INSUFFLATION UNIT

Catalog Number AS-IFS1

Device Problem No Apparent Adverse Event (3189)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

The report device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

Conmed (b)(4) reported on behalf of their customer that the as-ifs1, airseal unit was used in case where the patient had a stroke.The air seal pressure setting was 12 mmhg.After the patient saturation has been decreasing, stroke occurred.The patient got paralysis on the left side.The doctor commented "the patient has atrial septal defect.Also the doctor confirmed there are possibilities that this would occurred when abdominal insufflation is done to the patient who has atrial septal defect from the anesthesiology department." there is no indication that the airseal unit malfunctioned in any way.There is no actual complaint against the airseal, just that it was used in this procedure.Additional information and investigation has been requested but to date has not been received.As this was reported to the (b)(6) by conmed (b)(4), we are filing to the fda.

Manufacturer Narrative

The device will not be returned for evaluation and no photographic evidence was provided therefore root cause cannot be identified.Additionally, there is no reported allegation of device malfunction.The service history was reviewed, and no data was found.As the device has been in the field for more than 12 months, the dhr was not reviewed.A two-year review of complaint history revealed there has been 2 complaint regarding 2 device for this device family and failure mode.During the same time frame 3,176 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be.0006 per the instructions for use, the user is advised the following; - 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.- insufflating co2 may result in metabolic acidosis.- this can lead to cardiac irregularities expressed with the following symptoms: reduced aspiration with restricted diaphragm functions, hypercapnia and reduced cardiac output.- additionally, conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: AIRSEAL IFS 110V
• Type of Device: INSUFFLATION UNIT
• Manufacturer (Section D): W.O.M WORLD OF MEDICINE GMBH; salzufer 8; 4th floor; berlin, 10587 ; GM 10587
• MDR Report Key: 9545302
• MDR Text Key: 189020177
• Report Number: 3006217371-2019-00435
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K172516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AS-IFS1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other