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

Catalog Number AS-IFS1

Device Problems Increase in Pressure (1491); Human-Device Interface Problem (2949)

Patient Problems Air Embolism (1697); Death (1802)

Event Type  Death  

Manufacturer Narrative

The product is not expected to be returned, however the complaint investigation is ongoing.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

Conmed (b)(4) reported on behalf of their customer that the as-ifs1 was used in a urology procedure that resulted in a patient death on (b)(6) 2020.It was a davinci robotic surgery and airseal was used in this surgery.There was no airseal malfunction reported.The relationship between airseal and the surgical outcome is currently unknown.Another surgeon reported that the patient expired due to an air embolism.During the procedure the surgeon had increased the insufflation pressure to provide a hemostatic effect.Additional information is being gathered and will be reported when the investigation is concluded.This report is being raised based on device being in use when a patient expired.

Manufacturer Narrative

Additional information: on (b)(6)2020 additional information was received from a medical engineer, not a doctor, that the sequence of events that took place were; 1.During surgery, subcutaneous emphysema was observed 2.After surgery, in the hospital ward, it was confirmed that subcutaneous emphysema got severe 3.The patient was diagnosed with peripheral circulatory failure 4.The patient was diagnosed with sepsis 5.The patient expired.The date of the patient death is still unknown.The relationship between airseal and the patient death is still unknown.The previous filing the surgeon mentioned an air embolism, however, the medical engineer did not mention anything about an air embolism.There is still no report of airseal malfunctioning during the procedure.This is all the information that is available.This issue will continue to be monitored through the complaint system to assure patient safety.

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 performed 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 189 complaints regarding 189 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; - improper placement of the insufflation instrument could cause gas penetrating a vessel or internal organ, resulting in gas embolisms.- to reduce the risk, use 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 reached the nominal pressure value.- gas embolisms can also be caused by high intra-abdominal pressure.- avoid high-pressure settings and close damaged blood vessels at once.- failure to properly follow the instruction for use can lead to serious surgical consequences.This issue will continue to be monitored through the complaint system to assure patient safety.

Manufacturer Narrative

Previous reporting stated the date of death in b2 was (b)(6) 2020.That date has not been confirmed by conmed subsequently the actual date of death is not known.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: 9915542
• MDR Text Key: 186114731
• Report Number: 3006217371-2020-00163
• 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,Followup,Followup
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AS-IFS1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/02/2020
• Supplement Dates Manufacturer Received: 05/27/2020; 05/27/2020; 08/05/2020
• Supplement Dates FDA Received: 06/01/2020; 06/03/2020; 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DAVINCI ROBOT; DAVINCI ROBOT
• Patient Outcome(s): Death