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 Problems Stroke/CVA (1770); Infiltration into Tissue (1931); Paralysis (1997)

Event Type  Injury  

Manufacturer Narrative

Additional product code; gcj manufacturer narrative: reported event is inconclusive.The device will not be returned for evaluation and no photographic evidence has been provided; therefore, the reported event cannot be verified.A service history cannot not be conducted due to the unavailability of the serial number.A device history review cannot not be conducted as no serial number was provided.A two-year review of complaint history revealed there has been a total of 7 complaints, regarding 7 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 0.004.Per the instructions for use, the user is advised the following: higher insufflation pressures (>15mm hg) of carbon dioxide insufflation can increase the risk of hypercarbia, subcutaneous emphysema, pneumomediastinum, pneumothorax, pneumoscrotum and urinary retention.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The conmed (b)(4) reported on behalf of the customer reported that the as-ifs1, airseal ifs, 110v device was being used during a laparoscopic hepatectomy procedure around october 2017 when it was reported that "embolism occurred during laparoscopic hepatectomy using airseal.¿ after further assessment it was found, the patient had no patent foramen ovale and is diabetic and has high pressure.Cusa suction was used right before co2 gas embolism occurred.There was a hole (about 1mm) at the peripheral hepatic vein.Gas flow was 8mmhg.It was monitored that the vital sign of the patient was stabilized.There was a few minutes delay.It was necessary to monitor patient¿s condition.The patient went to another hospital during the hospitalization.Therefore, it is not known if the extension of the hospital stay was necessary.Patient condition:stroke, hemiplegia.This report is being raised on the basis injury of due to gas embolism.

• Brand Name: AIRSEAL IFS, 110V
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): W.O.M WORLD OF MEDICINE GMBH; salzufer 8,4th floor; berlin 10587 ; GM 10587
• Manufacturer (Section G): W.O.M WORLD OF MEDICINE GMBH; salzufer 8,4th floor; berlin 10587 ; GM 10587
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 12907705
• MDR Text Key: 286013466
• Report Number: 1320894-2021-00425
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• 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: 11/04/2021
• 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 Sex: Male
• Patient Ethnicity: Non Hispanic