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 Infiltration into Tissue (1931)

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 (b)(4).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 on an unknown date when it was reported that ¿about one year ago, co2 gas embolism occurred during laparoscopic hepatectomy using airseal.Saturation rapidly decreased.Insufflation was stopped.It took time for patient's recovery (longer than a standard insufflator).¿ after further assessment it was found, the procedure was converted to open because co2 gas embolism occurred.Gas flow setting was airseal mode and 8mmhg was used.Medically pure co2 was used.It is also noted that no device malfunction occurred during the reported incident.It was noted by a surgeon that "co2 gas embolism occurred also during open surgery.The relation between iap and cvp might be related to co2 gas embolism.However, if a patient would have heart disease, the effect could work vise-versa." there was a delay of an unknown amount of time.The patient was discharged and there was no prolonged hospitalization.This report is being raised on the basis injury of due to gas embolism and converting to an open surgery.

• 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: 12907589
• MDR Text Key: 286838073
• Report Number: 1320894-2021-00423
• 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

• 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
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 12/01/2021
• 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): Required Intervention; Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic