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

On 8dec23 the 36th congress of the endoscopic surgery society presented a workshop entitled safe endoscopic surgery considered from trouble cases and emergency laparotomy transitions.The as-ifs1, airseal ifs, 110v was reported as a, ¿69 year old man, s8 hepatocellular carcinoma.The patient had received 2 prior ca treatments for af.During hepatic superficial parenchymal transection, etco2 decreased.Transthoracic echocardiography showing numerous bubbles in the left atrium and paradoxical emboli.The disease was suspected.Transesophageal echocardiography showed right-to-left shunt.The patient underwent transection of the liver after laparotomy.The patient was discharged on postoperative day 7 without symptoms of cerebral infarction after awakening.¿.There was no report of the as-ifs1 having a malfunction.This report is being raised due to the reported injury of embolism.

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.Device history record (dhr) review cannot be conducted as a lot number was not provided.A two-year review of complaint history revealed there has been a total of 9 reports, regarding 10 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (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

On 8dec23 the 36th congress of the endoscopic surgery society presented a workshop entitled safe endoscopic surgery considered from trouble cases and emergency laparotomy transitions.The as-ifs1, airseal ifs, 110v was reported as a, ¿69 year old man, s8 hepatocellular carcinoma.The patient had received 2 prior ca treatments for af.During hepatic superficial parenchymal transection, etco2 decreased.Transthoracic echocardiography showing numerous bubbles in the left atrium and paradoxical emboli.The disease was suspected.Transesophageal echocardiography showed right-to-left shunt.The patient underwent transection of the liver after laparotomy.The patient was discharged on postoperative day 7 without symptoms of cerebral infarction after awakening.¿.There was no report of the as-ifs1 having a malfunction.This report is being raised due to the reported injury of embolism.

• 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: 18418398
• MDR Text Key: 331593984
• Report Number: 1320894-2023-00278
• 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,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

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: 12/08/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 01/29/2024
• 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 Age: 69 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic