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 Problems Air Embolism (1697); Brain Injury (2219)

Event Type  Injury  

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.

Event Description

In an article published online on 1 march 2023, titled, cerebral infarction by paradoxical gas embolism detected after laparoscopic partial hepatectomy with an insufflation management system: a case report, regarding the as-ifs1, airseal ifs, 110v, reported, ¿a male in his 60s was diagnosed with recurrence of liver metastasis in the right hepatic lobe after laparoscopic lower anterior resection for rectal cancer.We performed laparoscopic partial hepatectomy with an airseal® under 10 mmhg of intra-abdominal pressure.During the surgery, the patient¿s end-tidal co2 and percutaneous oxygen saturation dropped from approximately 40¿20 mmhg and 100¿90%, respectively, while the heart rate increased from 60 to 120 beats/min; his blood pressure remained stable.Postoperatively, the patient developed righ hemiplegia and aphasia.Brain magnetic resonance imaging showed cerebral infarction in the broad area of the left cerebral cortex.Thereafter, transesophageal echocardiography revealed a patent foramen ovale, suggesting cerebral infarction due to paradoxical gas embolism¿¿ it is unknown if this case has been reported to conmed previously.The article does not indicate a malfunction of the device.The patient was transferred to a rehabilitation hospital 21 days after the surgery.This report is being raised on the basis of injury due to cerebral infarction.

Manufacturer Narrative

The device is not being returned and upon careful review of the article, there is not enough information given in the article to suggest alleged deficiency of the airseal device.There was no contact information or location on where this incident occurred.There is no serial number of the device in question.There is no evidence of the device malfunction, or any reports of a warning associated with air entrainment stated in the article; 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 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 17 reports, regarding 17 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 0.00001.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

In an article published online on 1mar23, titled, cerebral infarction by paradoxical gas embolism detected after laparoscopic partial hepatectomy with an insufflation management system: a case report, regarding the as-ifs1, airseal ifs, 110v, reported, ¿a male in his 60s was diagnosed with recurrence of liver metastasis in the right hepatic lobe after laparoscopic lower anterior resection for rectal cancer.We performed laparoscopic partial hepatectomy with an airseal® under 10 mmhg of intra-abdominal pressure.During the surgery, the patient¿s end-tidal co2 and percutaneous oxygen saturation dropped from approximately 40¿20 mmhg and 100¿90%, respectively, while the heart rate increased from 60 to 120 beats/min; his blood pressure remained stable.Postoperatively, the patient developed righ hemiplegia and aphasia.Brain magnetic resonance imaging showed cerebral infarction in the broad area of the left cerebral cortex.Thereafter, transesophageal echocardiography revealed a patent foramen ovale, suggesting cerebral infarction due to paradoxical gas embolism.¿ it is unknown if this case has been reported to conmed previously.The article does not indicate a malfunction of the device.The patient was transferred to a rehabilitation hospital 21 days after the surgery.This report is being raised on the basis of injury due to cerebral infarction.

• 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: 17977102
• MDR Text Key: 326173608
• Report Number: 1320894-2023-00231
• 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,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• 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
• Date Manufacturer Received: 11/17/2023
• 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 Sex: Male
• Patient Ethnicity: Non Hispanic