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 Problem Air Embolism (1697)

Event Type  Injury  

Event Description

At the 36th congress of the endoscopic surgery society, it was reported in a presentation entitled ¿a case of gas-embolus occurring during laparoscopic partial hepatectomy using airseal¿ that: ¿hepatocellular carcinoma of 27mm was diagnosed in the hepatic s8 by contrast-enhanced ct of black stool examination during ambulatory treatment for alcoholic liver cirrhosis, and laparoscopic partial hepatectomy was performed.The line was made.Pneumoperitoneum was made by 10mmhg using airseal in the head elevation.During the second-cycle hepatic transection under pringle blockade, a steep decrease in etco2 20mmhg, spo292% was observed.Blood gas station paco2 67.4 and etco2 and the discrepancy were recognized in the viewpoint, and it was diagnosed as a gas embolism.With pure oxygenation and low head position, the operation was interrupted, and the liver transection plane was compressed, and the respiratory and circulatory dynamics were stabilized in a short time.The liver transection was resumed after 30 minutes, and it shifted to the laparotomy, because it became similar progress.The patient's respiratory condition was stable thereafter.Though there was no problem in the respiratory condition in the postoperative, the large drainage was recognized from the drain, and it was improved and left hospital on the 19th day.¿.This report is being raised due to the reported injury of gas embolism with no allegation of a device malfunction.

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

At the 36th congress of the endoscopic surgery society, it was reported in a presentation entitled ¿a case of gas-embolus occurring during laparoscopic partial hepatectomy using airseal¿ that: ¿hepatocellular carcinoma of 27mm was diagnosed in the hepatic s8 by contrast-enhanced ct of black stool examination during ambulatory treatment for alcoholic liver cirrhosis, and laparoscopic partial hepatectomy was performed.The line was made.Pneumoperitoneum was made by 10mmhg using airseal in the head elevation.During the second-cycle hepatic transection under pringle blockade, a steep decrease in etco2 20mmhg, spo292% was observed.Blood gas station paco2 67.4 and etco2 and the discrepancy were recognized in the viewpoint, and it was diagnosed as a gas embolism.With pure oxygenation and low head position, the operation was interrupted, and the liver transection plane was compressed, and the respiratory and circulatory dynamics were stabilized in a short time.The liver transection was resumed after 30 minutes, and it shifted to the laparotomy, because it became similar progress.The patient's respiratory condition was stable thereafter.Though there was no problem in the respiratory condition in the postoperative, the large drainage was recognized from the drain, and it was improved and left hospital on the 19th day.¿.This report is being raised due to the reported injury of gas embolism with no allegation of a device malfunction.

Manufacturer Narrative

The device will not be returned and no photographic evidence has been provided therefore the reported event cannot be verified.The service history could not be reviewed as a serial number was not provided.A device history record review could not be conducted as a serial number was not provided.(b)(4).Per the instructions for use (ifu), the user is advised the following: that 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.

• 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: 18400480
• MDR Text Key: 331418207
• Report Number: 1320894-2023-00272
• 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

• Date FDA Received: 12/27/2023
• 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: 01/11/2024
• 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; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic