MAUDE Adverse Event Report: SEQUEL SPECIAL PRODUCTS AIRSEAL 5/120LP PORT; AIRSEAL TROCAR

Catalog Number IAS5-120LP

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/19/2018

Event Type  Injury  

Manufacturer Narrative

The complaint is inconclusive.The device was not returned for evaluation and no photographic evidence was provided.The device history record was not reviewed as this product is not manufactured by conmed.A lot history review could not be done as no lot number was provided.A two-year review of complaint history revealed there has been 8 complaints regarding (b)(4) devices 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.Improper use of this product can result in life threatening injury or internal organs and vessels.Do not use excessive downward force.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported that the patient went to a follow up visit post-surgery that was performed on (b)(6) 2018.The doctor sent the patient for a ct scan and the scan found a 2-inch object in the patient.That object was the sound cap of the ias5-120lp, airseal trocar.It was removed during a secondary surgery.The hospital has filed a report with the fda per, the reporter.On january 17, 2019 - the medwatch was received and provided additional information that the piece located was 8cm in length, it was found in the mesentery tissue, it was a cylindrical structure.Once the foreign object was removed it was identified as a fractured portion of the outer lumen of a dual lumen airseal 5mm access port.This report is being raised based on patient injury.

Manufacturer Narrative

Additional information: the complaint was originally reported as inconclusive, but pictures and further information was received to confirm the event that was reported.The complete 8cm piece of the ias5-120lp, trocar sheath was removed completely during a secondary laparoscopic procedure.It was visually compared to an intact ias5-120lp.A determination for further investigation has been initiated.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: AIRSEAL 5/120LP PORT
• Type of Device: AIRSEAL TROCAR
• Manufacturer (Section D): SEQUEL SPECIAL PRODUCTS; 1 hillside dr; wolcott CT 06716
• MDR Report Key: 8277758
• MDR Text Key: 134097617
• Report Number: 1320894-2019-00003
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAS5-120LP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/27/2018
• Initial Date FDA Received: 01/25/2019
• Supplement Dates Manufacturer Received: 02/05/2019
• Supplement Dates FDA Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 95