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

At the 36th congress of the endoscopic surgery society on (b)(6) 2023, it was reported in a presentation (title unknown) that ¿a 79-year-old man.Tatme was performed for rectal ra carcinoma.On the 3rd postoperative day, the patient had a fever and a feeling of warmth in the right lower abdomen, and ct imaging revealed subcutaneous emphysema and edematous changes around 12mm port-insertion site in the right lower abdomen.The possibility of the intraperitoneal infection was also considered.Mepm was completed, the drainage was completed on postoperative day 14, and the patient was discharged from the hospital on postoperative day 21¿.In this case, intraperitoneal manipulation with transiently elevated pneumoperitoneum pressure (15mmhg) may be responsible for subcutaneous emphysema.Factors complicated by infection include the close distance between 5mm port and the covering stoma on the right side of the umbilicus and the history of diabetes mellitus.'.This report is being raised due to the reported injury of subcutaneous emphysema with no allegation of malfunction of the device.

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, 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.(b)(4).Per the instructions for use, the user is advised: that 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

At the (b)(6) on (b)(6) 2023, it was reported in a presentation (title unknown) that ¿a 79-year-old man.Tatme was performed for rectal ra carcinoma.On the 3rd postoperative day, the patient had a fever and a feeling of warmth in the right lower abdomen, and ct imaging revealed subcutaneous emphysema and edematous changes around 12mm port-insertion site in the right lower abdomen.The possibility of the intraperitoneal infection was also considered¿.Mepm was completed, the drainage was completed on postoperative day 14, and the patient was discharged from the hospital on postoperative day 21¿.In this case, intraperitoneal manipulation with transiently elevated pneumoperitoneum pressure (15mmhg) may be responsible for subcutaneous emphysema.Factors complicated by infection include the close distance between 5mm port and the covering stoma on the right side of the umbilicus and the history of diabetes mellitus.".This report is being raised due to the reported injury of subcutaneous emphysema with no allegation of malfunction of the device.

• 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 18400344
• MDR Text Key: 331416404
• Report Number: 1320894-2023-00275
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

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: 12/09/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 01/15/2024
• Supplement Dates FDA Received: 01/16/2024
• 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): Required Intervention; Other; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic