MAUDE Adverse Event Report: CONMED CORPORATION AIRSEAL 12MM ACCESS PORT AND OBTURATOR WITH BLADELESS OPTICAL TIP, 150MM LENGTH; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number IAS12-150

Device Problems Break (1069); Crack (1135); Entrapment of Device (1212); Material Deformation (2976)

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

Event Date 12/02/2016

Event Type  malfunction  

Manufacturer Narrative

The used/damaged airseal 12mm access port was returned to conmed for evaluation on (b)(6) 2016.To date, the investigation remains in progress and a supplemental and final report will be filed upon the completion of the complaint investigation.

Event Description

The user facility reported that a "large crack" was discovered on the airseal 12mm access port at the end of the case.Follow-up with the user facility revealed that the robotic-assisted mediastinal mass removal procedure on (b)(6) 2016 went very well and that the surgery was completed as planned with no issues noted.However, as the port was being removed at the end of the case, the port was found broken in a couple pieces inside the patient.Broken pieces were safely removed with no problems noted and no surgical delay reported.The procedure was completed with no serious injury and the patient was discharged as per routine procedure for this type of surgery.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 used/damaged airseal 12mm access port was returned for evaluation.Visual examination of the returned device found the unit was received in poor condition and the distal outer layer of the cannula was cracked and pieces broken off from the inner tube.Further inspection of the cannula on the opposite side of the broken section showed cracking.This cracking is evidence of an external load was applied to the cannula.Based on available information and evaluation of the returned device, the quality engineer believed that the most probable cause of this reported problem was use related, in that external load applied to the cannula might have contributed to the cracking to a point of pieces being broken off during removal of the cannula.A review of the device history record for this device could not be performed, as the lot number was not provided.A 2-year review of the device complaint history shows there have been no other similar complaints received.This failure mode is addressed in the dfmea, and the safety risk has been found to be acceptable.To date, there have been no patient long term adverse effects resulting from this type of reported incidents.No further action is planned at this time.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 AND OBTURATOR WITH BLADELESS OPTICAL TIP, 150MM 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: 6215779
• MDR Text Key: 63868070
• Report Number: 3006217371-2016-00042
• 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: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAS12-150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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