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 No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device is not being returned and no photograph evidence was provided.Therefore, the reported failure could not be verified.The service history could not be reviewed since a serial number was not provided.A review of the dhr could not be performed since a serial number was not provided.A two-year review of complaint history revealed there has been 139 complaints regarding 139 devices for this device family and failure mode.During the same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following; 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.Improper placement of the insufflation instrument could cause gas penetrating a vessel or an integral organ, resulting in gas embolisms.To reduce this 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.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.

Event Description

Conmed (b)(4) reported on behalf of their customer that the as-ifs1, airseal unit was used during a robotic assisted hepatectomy.During the procedure the surgeon could observe that co2 was penetrated into the hepatic vein (it occurred during liver resection) the spo2 was decreased and the surgeon judged that a gas embolism occurred and stopped the use of airseal.There is no report that the airseal malfunctioned in any way.There is no allegation that anything was wrong with the device.The surgeon completed the procedure as planned with another insufflation device, not conmed, brand unknown.There is no report of patient injury, there is not report of any extended hospitalization.Based on the information provided this does not meet the definition of a reportable event, however, (b)(4) did file with the pmda, and to align with their reporting we will file to the fda.This report is being raised to align with the conmed reporting in (b)(6).

• 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
• Manufacturer (Section G): W.O.M WORLD OF MEDICINE GMBH; salzufer 8; 4th floor; berlin, 10587 ; GM 10587
• Manufacturer Contact: melanie lannon ; 11311 concept boulevard; largo, fl ; 3995209
• MDR Report Key: 9722533
• MDR Text Key: 205341695
• Report Number: 3006217371-2020-00058
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2020

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: 01/21/2020
• Initial Date FDA Received: 02/18/2020
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1