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 Type  Injury  

Event Description

In the 37th annual meeting of the japanese society of urological endoscopy and robotics preview on 13nov23, pertaining to experience with cerebral gas embolism during robot-assisted surgery and countermeasures against carbon dioxide embolism referencing the as-ifs1, airseal ifs, 110v device it was reported, ¿we experienced a case in which gas embolism occurred in the brain following pulmonary embolism, and the treatment course was disappointing.A (b)(6)-year-old man was diagnosed with right renal cancer.During the resection, etco2 decreased and a carbon dioxide plug was suspected, so we continued to lower the pneumoperitoneum pressure and suture the resected surface.After the surgery, the patient awoke from general intoxication and returned to the hospital room, but after further examination, the patient was diagnosed with cerebral gas embolism¿.It is unknown if this case has been reported to conmed previously.The discussion does not indicate a malfunction of the device.5 cases of intraoperative cerebral gas embolization were reported and only 1 case study was discussed.This report is being raised on the basis of injury due to cerebral gas 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.

Manufacturer Narrative

The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.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 (b)(4) reports, regarding (b)(4) 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, 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.

Event Description

In the 37th annual meeting of the japanese society of urological endoscopy and robotics preview on 13nov23, pertaining to experience with cerebral gas embolism during robot-assisted surgery and countermeasures against carbon dioxide embolism referencing the as-ifs1, airseal ifs, 110v device it was reported, ¿we experienced a case in which gas embolism occurred in the brain following pulmonary embolism, and the treatment course was disappointing.A 77-year-old man was diagnosed with right renal cancer.During the resection, etco2 decreased and a carbon dioxide plug was suspected, so we continued to lower the pneumoperitoneum pressure and suture the resected surface.After the surgery, the patient awoke from general intoxication and returned to the hospital room, but after further examination, the patient was diagnosed with cerebral gas embolism¿.It is unknown if this case has been reported to conmed previously.The discussion does not indicate a malfunction of the device.5 cases of intraoperative cerebral gas embolization were reported and only 1 case study was discussed.This report is being raised on the basis of injury due to cerebral gas 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: 18257878
• MDR Text Key: 329621035
• Report Number: 1320894-2023-00261
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K190303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

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?: No
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 12/04/2023
• Supplement Dates Manufacturer Received: 12/12/2023
• Supplement Dates FDA Received: 12/15/2023
• 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
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic