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  

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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

An article published in an abstract collection of the 15th annual meeting of the japanese society of robotic surgery under the title ``ingenuity to reduce subcutaneous emphysema in robotic gastrectomy'', regarding the as-ifs1, airseal ifs, 110v, which is believed to have been used during a robotic gastrectomy procedure during the time frame of june 2019 through november 2021 has reported, ¿a retrospective study of clinicopathological factors, the incidence of subcutaneous emphysema, and creative ideas for reducing subcutaneous emphysema in 74 cases.¿.It is unknown if any or all of these cases have been reported to conmed previously.The article does not indicate a malfunction of the device nor state any medical intervention or hospitalization for any patient.This report is being raised on the basis of injury due to the article reporting subcutaneous emphysema.

Manufacturer Narrative

The device will not be returned, and no photographic evidence was provided.Therefore, the reported event cannot be verified.The manufacturing documents from the device history record have not been reviewed because the serial number of the device is not known.The service history of the device has not been reviewed because the serial number of the device is not known.(b)(4).Per the instructions for use, the user is advised that the incorrect placement of a cannula or a trocar into subcutaneous tissue may lead to emphysema.To reduce the risk, use a low gas flow rate for the first insufflation and ensure that the insufflation instrument is correctly positioned.Long surgeries (> 200 min.), the use of many access points, duration and size of leaks at these points may also contribute to emphysema.Be sure to close leakages in trocar access points immediately.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

An article published in an abstract collection of the 15th annual meeting of the japanese society of robotic surgery under the title ``ingenuity to reduce subcutaneous emphysema in robotic gastrectomy'', regarding the as-ifs1, airseal ifs, 110v, which is believed to have been used during a robotic gastrectomy procedure during the time frame of (b)(6) 2019 through (b)(6) 2021 has reported, ¿a retrospective study of clinicopathological factors, the incidence of subcutaneous emphysema, and creative ideas for reducing subcutaneous emphysema in 74 cases.¿.It is unknown if any or all of these cases have been reported to conmed previously.The article does not indicate a malfunction of the device nor state any medical intervention or hospitalization for any patient.This report is being raised on the basis of injury due to the article reporting subcutaneous emphysema.

• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 16403404
• MDR Text Key: 309905724
• Report Number: 1320894-2023-00043
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• 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?: Yes
• Date Manufacturer Received: 02/24/2023
• 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