MAUDE Adverse Event Report: SEQUEL SPECIAL PRODUCTS AIRSEAL IAS12-120LPI; 12/120MM PORT/TROCAR

Catalog Number IAS12-120LPI

Device Problems Positioning Problem (3009); Patient Device Interaction Problem (4001)

Patient Problems Laceration(s) (1946); Great Vessel Perforation (2152)

Event Date 07/30/2019

Event Type  Injury  

Manufacturer Narrative

The report device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The conmed representative reported on behalf of the facility that the ias12-120lpi, airseal port access trocar, struck the ivc (inferior vena cava) and descending aorta, the 2 major intra-abdominal vessels, while inserting the port for a robotic bowel resection on (b)(6) 2019.The procedure was stopped and converted to an open procedure, a vascular surgeon was called in to repair the damaged vessels.The patient required a blood transfusion and vascular surgeon intervention.The original procedure was not completed as planned.There was over a 30-minute delay due to the emergent surgical intervention that was required.To date, the status of the patient is unknown and investigation is ongoing to determine if the access port was at fault or if the patient had unusual circumstances or anatomy that led to this incident.This report is being raised due to patient injury.

Manufacturer Narrative

Additional information: the patient has undergone the original procedure, bowel resection, the week of (b)(6) 2019, exact date unknown, it was performed as an open procedure.Complaint is inconclusive.The device will not be returned for evaluation and no photographic evidence was provided therefore root cause cannot be identified.A 2 year lot history review could not be performed, as a lot number was not provided.A dhr review cannot be conducted as a lot number was not provided.A two-year review of complaint history revealed there has been 1 complaint regarding 1 device for this device family and failure mode.During the same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following; - use extreme caution during airseal access port insertion as improper use of this product can result in life-threatening injury to internal organs and vessels.- ensure that the patient is properly positioned so that organs are away from the penetration site.- additionally, only qualified physicians with knowledge, experience and training in laparoscopic technique should use the components of the airseal access system.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: AIRSEAL IAS12-120LPI
• Type of Device: 12/120MM PORT/TROCAR
• Manufacturer (Section D): SEQUEL SPECIAL PRODUCTS; 1 hillside dr; wolcott CT 06716
• MDR Report Key: 8865108
• MDR Text Key: 153403885
• Report Number: 1320894-2019-00263
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K143404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IAS12-120LPI
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other