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 02/19/2024

Event Type  Injury  

Event Description

Conmed japan reported on behalf of their customer that the device, as-ifs1, airseal ifs, 110v was being used on 19feb24 during a thoracoscope-assisted subtotal esophagectomy procedure and ¿during the surgery, the patient was put into air seal mode, but because the lungs could not be pumped out, the air seal was discontinued and another pneumoperitoneum was used to continue the surgery.Surgeons later confirmed that he may have developed subcutaneous emphysema while using air seal.Nothing was said during the surgery.¿.After further assessment it was found that the patient did develop subcutaneous emphysema.Clarification regarding "lungs could not be pumped out" was provided."in thoracoscopic malignant esophagectomy, the lungs narrow the surgical field and get in the way, so the surgery is performed with one lung collapsed.Furthermore, pneumoperitoneum device is used to create a situation in which the lungs are artificially crushed.In this event, the air seal used as the pneumoperitoneum device was unable to compress the lungs.¿ there was a 15 minute delay to the procedure.There was no report of medical intervention or prolonged hospitalization to the patient.This report is being raised on the reported injury of patient developing subcutaneous emphysema.

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, the reported event 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.(b)(4).Per the instructions for use, the user is advised the following: 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

Update: per further assessment, no device malfunction was reported.Conmed japan reported on behalf of their customer that the device, as-ifs1, airseal ifs, 110v was being used on (b)(6) 2024 during a thoracoscope-assisted subtotal esophagectomy procedure and ¿during the surgery, the patient was put into air seal mode, but because the lungs could not be pumped out, the air seal was discontinued and another pneumoperitoneum was used to continue the surgery.Surgeons later confirmed that he may have developed subcutaneous emphysema while using air seal.Nothing was said during the surgery." after further assessment it was found that the patient did develop subcutaneous emphysema.Clarification regarding "lungs could not be pumped out" was provided."in thoracoscopic malignant esophagectomy, the lungs narrow the surgical field and get in the way, so the surgery is performed with one lung collapsed.Furthermore, pneumoperitoneum device is used to create a situation in which the lungs are artificially crushed.In this event, the air seal used as the pneumoperitoneum device was unable to compress the lungs." there was a 15 minute delay to the procedure.There was no report of medical intervention or prolonged hospitalization to the patient.This report is being raised on the reported injury of patient developing 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 18977777
• MDR Text Key: 338586558
• Report Number: 1320894-2024-00081
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

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?: No
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 04/05/2024
• Supplement Dates FDA Received: 04/16/2024
• 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
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic