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

Catalog Number AS-IFS1

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

Patient Problem Air Embolism (1697)

Event Date 02/07/2024

Event Type  Injury  

Event Description

The customer reported that the as-ifs1, airseal ifs, 110v was being used on approximately (b)(6) 2024 and during a robotic nephrectomy the patient had an air embolism.The airseal was set at 15 mm hg.The patient has a long history of health issues which includes obesity.About an hour into the procedure the patient¿s stats dropped and the procedure was aborted.The patient was admitted to the icu and was still there on (b)(6) 2024.The patient will be re-scheduled to have open surgery.The ias12-100lpi, airseal 12/100mm lpi port and the asm-evac1, trilumen filtered tube set are concomitant devices and there is no allegation against them.This report is being raised due to the reported injury of patient receiving an air embolism.

Manufacturer Narrative

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.We will continue to monitor for trends through the complaint system to assure patient safety.

Manufacturer Narrative

The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.If the device is returned at a later date, the investigation may be updated and reanalyzed.The service history review cannot be conducted as a serial number was not provided.A device history record (dhr) review cannot be conducted as a serial number was not provided.A two-year review of complaint history revealed there has been a total of 12 reports, regarding 13 devices, for this device family and failure mode.(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 an internal organ, resulting in gas embolisms.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.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The customer reported that the as-ifs1, airseal ifs, 110v was being used on approximately 7feb24 and during a robotic nephrectomy the patient had an air embolism.The airseal was set at 15 mm hg.The patient has a long history of health issues which includes obesity, about an hour into the procedure the patient¿s stats dropped and the procedure was aborted.The patient was admitted to the icu and was still there on (b)(6) 2024.The patient will be re-scheduled to have open surgery.The ias12-100lpi, airseal 12/100mm lpi port and the asm-evac1, trilumen filtered tube set are concomitant devices and there is no allegation against them.This report is being raised due to the reported injury of patient receiving an air embolism.

• Brand Name: AIRSEAL IFS, 110V
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin 10587 ; GM 10587
• Manufacturer (Section G): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin 10587 ; GM 10587
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 18787311
• MDR Text Key: 336291860
• Report Number: 1320894-2024-00044
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

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-IFS1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 03/04/2024
• Supplement Dates FDA Received: 03/07/2024
• 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
• Patient Sequence Number: 1
• Treatment: ASM-EVAC1, TRILUMEN FILTERED TUBE; ASM-EVAC1, TRILUMEN FILTERED TUBE; IAS12-100LPI, AIRSEAL 12/100MM LPI; IAS12-100LPI, AIRSEAL 12/100MM LPI
• Patient Outcome(s): Other; Hospitalization
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic