MAUDE Adverse Event Report: CONMED CORPORATION AIRSEAL 12MM ACCESS PORT & PALM GRIP OBTURATOR W/ BLADELESS OPTICAL TIP, 100MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number IAS12-100LPI

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/18/2016

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 was not returned.

Event Description

The user facility reported that during use of the airseal 12mm access port in a robotic prostatectomy on (b)(6) 2016, the "blue seal" from the airseal sound cap was dislodged and went into the patient.The "whole blue rubber piece" was safely removed with no problems noted.The airseal 12mm access port remained in use to complete the case and was discarded at the user facility after the surgery.Other than a few second that it took to remove the detached "blue rubber seal", no surgical delay and the procedure was otherwise completed successfully with no further complications or patient injury.The male patient was discharged as per routine procedure for this type of surgery.This report is filed on the basis of potential injury with recurrence.

Manufacturer Narrative

As reported, the involved airseal 12mm access port was used to complete the procedure and discarded afterward at the user facility, hence the unit will not be returned for evaluation.Without the actual product, an evaluation could not be performed and the root cause of the reported breakage was not able to be determined.However, based on available information, it is believed that the most probable cause of the blue rubber sound cap detachment was use related in that the blue rubber seal got caught by an instrument or suture and was stretched to a point of being detached.This device is a vendor item and the certificate of conformance indicated that the product from this lot #59216 met final inspection and product release acceptance criteria.Of the lot containing (b)(4) units there were no other similar complaints received.This reported problem was obvious to the user and surgical staff and would prompt the use of an alternate device.To date, there have been no serious injuries or death related to the reported breakage.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.Device was not returned.

• Brand Name: AIRSEAL 12MM ACCESS PORT & PALM GRIP OBTURATOR W/ BLADELESS OPTICAL TIP, 100MM
• 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 blvd.; largo, FL 33773 ; 7273995515
• MDR Report Key: 6101721
• MDR Text Key: 60432443
• Report Number: 3006217371-2016-00036
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2016

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 Expiration Date: 07/13/2019
• Device Catalogue Number: IAS12-100LPI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2016
• Initial Date FDA Received: 11/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2016
• 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