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

Catalog Number AS-IFS1

Device Problem Insufficient Information (3190)

Patient Problems Air Embolism (1697); Paralysis (1997); Ischemia Stroke (4418)

Event Date 02/07/2023

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

Conmed japan reported on behalf of the customer that the as-ifs1, airseal ifs, 110v device was being used during a laparoscopic partial liver resection procedure on (b)(6) 2023 when it was reported ¿a patient who underwent laparoscopic partial liver resection (s7 + s8) on february 7 (tue) developed cerebral infarction.Left-sided paralysis because it occurred on the right side of the brain.He is said to be on the road to recovery.Based on the test values, there is a high possibility of co2 embolism, and we asked for an interview because we were told that it might be a complication caused by airseal.In dr.'s opinion, since he had a history of hepatitis c and had severe cirrhosis, the blood vessels were exposed, so inflow from the vascular skin is conceivable.In addition, the patient had a congenital defect of a patent foramen ovale, so that the influx of gas passed from the inferior vena cava to the right atrium through the foramen ovale and into the left atrium.After that, it may have then moved to the brain." the procedure was completed with no delay reported.There was no report of extended hospitalization for the patient.The current status of the patient is ¿on the road to recovery¿.This report is being raised on the basis of injury due to patient developing cerebral infarction.

Manufacturer Narrative

The device will not be returned, and no photographic evidence was provided.Therefore, the reported event cannot be verified.A device history review cannot be conducted as a serial number was not provided.The service history review cannot be conducted as a serial number was not provided.(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

Conmed japan reported on behalf of the customer that the as-ifs1, airseal ifs, 110v device was being used during a laparoscopic partial liver resection procedure on (b)(6) 2023 when it was reported ¿a patient who underwent laparoscopic partial liver resection (s7 + s8) on (b)(6) (tue) developed cerebral infarction.Left-sided paralysis because it occurred on the right side of the brain.He is said to be on the road to recovery.Based on the test values, there is a high possibility of co2 embolism, and we asked for an interview because we were told that it might be a complication caused by airseal.In dr.'s opinion, since he had a history of hepatitis c and had severe cirrhosis, the blood vessels were exposed, so inflow from the vascular skin is conceivable.In addition, the patient had a congenital defect of a patent foramen ovale, so that the influx of gas passed from the inferior vena cava to the right atrium through the foramen ovale and into the left atrium.After that, it may have then moved to the brain." the procedure was completed with no delay reported.There was no report of extended hospitalization for the patient.The current status of the patient is ¿on the road to recovery¿.This report is being raised on the basis of injury due to patient developing 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 16484924
• MDR Text Key: 310685331
• Report Number: 1320894-2023-00048
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 03/06/2023
• Supplement Dates Manufacturer Received: 03/09/2023
• Supplement Dates FDA Received: 03/21/2023
• 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