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 Embolism/Embolus (4438)

Event Date 01/25/2023

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 japan reported on behalf of their customer that the device, as-ifs1 airseal ifs, 110v was being used on (b)(6) 2023 during a robot-assisted left partial nephrectomy procedure when it was reported that post-operatively ¿pneumoperitoneum with a retroperitoneal approach.The pneumoperitoneum pressure was 15.Co2 embolization occurred¿.The procedure was completed without an alternate device.Further assessment found there was ¿prolonged operation time and length of hospital stay.Operation time was 6 hours.The number of ports used was 6.No alarm sounded while in use¿.The delay of 1 hour was caused by the change from a laparoscopic procedure to an open abdomen procedure.This report is being raised on the basis of injury due to co2 embolism and the change from a laparoscopic to open procedure.

Manufacturer Narrative

The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.The service history was reviewed, and no data was found.A device history record review was requested from the manufacturer, and no indication of abnormalities was communicated.A two-year review of complaint history revealed there has been a total of 16 reports, regarding 16 devices, for this device family and failure mode.During this same time frame 966,822 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 0.00002.Per the instructions for use, the user is advised the following: higher insufflation pressures (> 15 mm hg) of carbon dioxide insufflation can increase the risk of hypercarbia, subcutaneous emphysema, pneumomediastinum, pneumothorax, pneumoscrotum and urinary retention.Use extreme caution during airseal access port insertion.Improper use of this product can result in life-threatening injury to internal organs and vessels.Ensure that adequate pneumoperitoneum or pneumorectum is established; ensure that the patient is properly positioned so that organs are away from the penetration site; direct the airseal access port¿s tip away from significant vessels and organs; do not use excessive downward force; once a safe and proper entry has been achieved, ensure that the black line at the distal tip of the airseal access port is visible within the cavity at all times the airseal access port is being used for insufflation.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

Conmed japan reported on behalf of their customer that the device, as-ifs1 airseal ifs, 110v was being used on (b)(6) 2023 during a robot-assisted left partial nephrectomy procedure when it was reported that post-operatively ¿pneumoperitoneum with a retroperitoneal approach.The pneumoperitoneum pressure was 15.Co2 embolization occurred¿.The procedure was completed without an alternate device.Further assessment found there was ¿prolonged operation time and length of hospital stay.Operation time was 6 hours.The number of ports used was 6.No alarm sounded while in use¿.The delay of 1 hour was caused by the change from a laparoscopic procedure to an open abdomen procedure.This report is being raised on the basis of injury due to co2 embolism and the change from a laparoscopic to open procedure.

• 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: 16362186
• MDR Text Key: 309382634
• Report Number: 1320894-2023-00035
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 10851885004587
• UDI-Public: 011085188500458711220119
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• 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?: Yes
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic