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 Date 07/16/2022

Event Type  Injury  

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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

Conmed (b)(4) reported on behalf of the customer that the as-ifs1, airseal ifs, 110v was being used on (b)(6) 2022 during a robotic assisted laparoscopic radical prostatectomy procedure when it was reported ¿the patient became infected with subcutaneous emphysema after the operation and is currently taking medication.¿ further assessment found "no device failures reported.¿ the procedure was completed with a no report of delay.Medical intervention was required for the patient and received medication to treat the subcutaneous emphysema.It is unknown if there was extended hospitalization for patient and current status of the patient is unknown.This report is being raised on the basis of injury due to subcutaneous emphysema.This report is being raised on the basis of injury due to subcutaneous emphysema.

Manufacturer Narrative

Reported event of subcutaneous emphysema is inconclusive.The device is not being returned and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.A device history review was not conducted as the device has been in the field more than 12 months.The service history was reviewed, and no data was found.A two-year review of complaint history revealed there has been a total of 5 complaints, regarding 5 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 ifu, 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.Additionally, higher insufflation pressures (> 15 mm 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

Conmed japan reported on behalf of the customer that the as-ifs1, airseal ifs, 110v was being used on 16jul22 during a robotic assisted laparoscopic radical prostatectomy procedure when it was reported ¿the patient became infected with subcutaneous emphysema after the operation and is currently taking medication.¿ further assessment found "no device failures reported.¿ the procedure was completed with a no report of delay.Medical intervention was required for the patient and received medication to treat the subcutaneous emphysema.It is unknown if there was extended hospitalization for patient and current status of the patient is unknown.This report is being raised on the basis of injury due to subcutaneous emphysema.

• 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 15192910
• MDR Text Key: 297534763
• Report Number: 1320894-2022-00173
• 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,Followup
• Report Date: 09/12/2022

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
• Device Lot Number: 1908CE0654
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2022
• Initial Date FDA Received: 08/09/2022
• Supplement Dates Manufacturer Received: 08/23/2022
• Supplement Dates FDA Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Ethnicity: Non Hispanic