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

Catalog Number IAS12-120LPI

Device Problems Crack (1135); Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

The device is not being returned but photographic evidence was provided that confirmed the reported problem.A two-year lot history review could not be performed since a lot number was not provided.A review of the dhr could not be performed since a lot number was not provided.A two-year review of complaint history revealed there has been 10 complaints regarding 10 devices for this device family and failure mode.During the same time frame 837,046 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be.00001.Per the instructions for use, the user is advised the following; 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 the adequate pneumoperitoneum or pneumorectum is established; ensure that the patient is properly positions 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.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 12/120mm port's outer lumen tip broke off during a robotic nephrectomy on (b)(6) 2020.The defect was not noticed until the end of the surgery, another port was used to complete the procedure.The port and the cracked piece were accounted for.There was no patient injury or impact.There was a 5-minute delay to get another port.The team was familiar with the device and the defect did not signal a problem.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Previous report filed on 2/3/2020 stated: a two-year lot history review could not be performed since a lot number was not provided.A review of the dhr could not be performed since a lot number was not provided.Additional information was provided on 2/7/20.The information included the lot number of the product.There fore the investigation has been updated, see below; a two-year lot history review shows this is the only complaint for this lot number and failure mode.A review of the dhr could not be performed since the device is not manufactured by conmed.This issue will continue to be monitored through the compalint suystem to assure patient safety.

• Brand Name: AIRSEAL 12/120MM LPI PORT
• Type of Device: AIRSEAL TROCAR
• Manufacturer (Section D): SEQUEL SPECIAL PRODUCTS; 1 hillside dr; wolcott CT 06716
• MDR Report Key: 9660231
• MDR Text Key: 183305860
• Report Number: 1320894-2020-00018
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAS12-120LPI
• Device Lot Number: 119819
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1