MAUDE Adverse Event Report: CONMED CORPORATION AIRSEAL 12MM ACCESS PORT & OBTURATOR WITH BLADELESS OPTICAL TIP, 120MM LENGTH; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number IAS12-120

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105); Entrapment of Device (1212)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

As of this filing, the investigation remained in progress.A supplemental and final report will be filed upon the completion of the product evaluation and the complaint investigation.Device has not been returned.

Event Description

The user facility reported that during use of the airseal 12 mm access port in a robotic-assisted retroperitoneal transabdominal lymphadenectomy on (b)(6) 2016, "piece of blue rubber seal" from the airseal sound cap had fallen off the trocar.This was noticed during the second half of the case and the detached blue piece was found inside the patient.Received information from the user facility indicated that the detachment might have occurred while items was being passed through the trocar, but unsure of the exact moment.The blue rubber piece was safely removed with no problems noted.Other than a minor delay to retrieve the rubber piece, the procedure was otherwise completed as planned with no further complications or patient injury.Despite the good faith efforts, no patient demographic information could be obtained from the user facility.This report is filed on the basic of potential injury with recurrence.

Manufacturer Narrative

One (1) used/damaged airseal12 mm access port was returned from the user facility to conmed corporation for evaluation.Visual inspection of the returned device found the whole "blue rubber seal" was detached from the sound reduction cap.Further evaluation from the engineer confirmed that the sound reduction seal was disengaged and that the sound cap showed evidence of the seal being over stretched.Overstretching and tearing of the seal can be caused by inserting a large or sharp device through the access port.Based on the evaluation findings, it is believed that the most probable cause of this reported breakage was use related.This device is a vendor item and the certificate of conformance indicated that the product from this lot #59716 met final inspection and product release acceptance criteria.The lot was manufactured on 03-aug-2016.Of the lot containing 984 units there were no other similar complaints received.This reported problem was obvious to the user and prompted the use of an alternate device.There have been no serious injuries or death related to the reported breakage.This complaint will continue to be monitored via the complaint system to ensure product safety.This failure mode is addressed in the dfmea, and the safety risk has been found to be acceptable.The airseal® ifs system is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments and to evacuate surgical smoke.It is indicated to facilitate the use of various laparoscopic instruments by filling the abdominal cavity with gas to distend it by creating and maintaining a gas sealed, obstruction free path and by evacuating surgical smoke.The airseal® ifs cannula and trocar system is composed of a sterile single use instrument consisting of a bladeless optical obturator and radiolucent cannula.To reduce the risk of patient injury, the as-ifs instructions for use (ifu) provides the following warnings: failure to properly follow the instructions for use can lead to serious surgical consequences.Only qualified physicians with knowledge, experience and training in laparoscopic techniques should use the components of the airseal access system.These instructions for use do not include descriptions or instructions for surgical techniques or laparoscopic procedures.It is the responsibility of the physician performing any procedure to determine the appropriateness of the type of procedure to be performed with the use of these products and to determine the specific technique for each patient.

• Brand Name: AIRSEAL 12MM ACCESS PORT & OBTURATOR WITH BLADELESS OPTICAL TIP, 120MM LENGTH
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): SEQUEL SPECIAL PRODUCTS; 122 avenue of industry; waterbury CT 06705
• Manufacturer Contact: brenda johnson ; 11311 concept boulevard; largo, FL 33773 ; 7273995515
• MDR Report Key: 6226796
• MDR Text Key: 64342715
• Report Number: 3006217371-2016-00043
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2019
• Device Catalogue Number: IAS12-120
• Device Lot Number: 59716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1