MAUDE Adverse Event Report: SEQUEL SPECIAL PRODUCTS AIRSEAL 5/120MM PORT; INSUFFLATION PORT

Catalog Number IAS5-120LP

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2020

Event Type  malfunction  

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 customer reported that the ias5-120lp, airseal 5/120mm port was used during a laparoscopic gastric bypass on (b)(6) 2020.At the end of the procedure the surgeon noticed that part of the trocar sleeve was broken off and it was stuck in the incision.The piece was retrieved and there was no reported patient impact or injury.The procedure was completed as planned with no delays reported.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Received one ias5-120lp in unoriginal packaging.Lot number was not verified.Performed a visual inspection, the trocar sleeve had broke in half.It appears that all pieces were returned.A two-year lot history review shows this is the only complaint for this lot number and failure mode.The device history record was requested to the supplier but has yet to be received.A two-year review of complaint history revealed there has been 12 complaints regarding 12 devices for this device family and failure mode.During the same time frame 732,466 devices have been manufactured and shipped worldwide.(b)(4).Per the instructions for use, the user is advised the following; failure to properly follow the instructions for use can lead to serious surgical consequences.Do not use excessive downward force.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: AIRSEAL 5/120MM PORT
• Type of Device: INSUFFLATION PORT
• Manufacturer (Section D): SEQUEL SPECIAL PRODUCTS; 1 hillside dr; wolcott, ct
• MDR Report Key: 9750358
• MDR Text Key: 183312372
• Report Number: 1320894-2020-00055
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAS5-120LP
• Device Lot Number: 62517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Date Manufacturer Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1