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 Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 04/20/2016

Event Type  malfunction  

Manufacturer Narrative

As of this filing, the used/damaged airseal 12mm access port has not been returned/received from the user facility for evaluation.A supplemental and final report will be filed upon the completion of the product evaluation and the complaint investigation.

Event Description

The customer reported that during use of this airseal 12mm access port in a robotic prostatectomy procedure, the "blue inner seal" broke off in the patient.This was discovered at the end of the procedure and thus there was no surgical delay.The "blue inner seal" was immediately retrieved with no problems note and the procedure was otherwise completed with no patient injury.The (b)(6), male patient was discharged as per routine procedure for this type of surgery.To date, there has been no additional information received regarding the patient's latest condition or any indication that a long term adverse effect has occurred.

Manufacturer Narrative

As reported, the used/damaged airseal 5mm access port was retained by the risk management at the user facility and 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, the quality engineer believed that it was most likely that the blue inner seal got caught by an instrument or suture and was stretched to a point of being torn.This device is a vendor item and the certificate of conformance indicated that the product from this lot #067-16 met final inspection and product release acceptance criteria.Of the lot containing (b)(4) units there were no other similar complaints received.This failure mode is addressed in the dfmea, and the safety risk has been found to be acceptable.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.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.: device has not yet 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): SURGIQUEST, INC.; 488 wheelers farms road; milford CT 06461
• Manufacturer Contact: brenda johnson ; 11311 concept blvd.; largo, FL 33773 ; 7273995515
• MDR Report Key: 5673957
• MDR Text Key: 46860969
• Report Number: 3006217371-2016-00014
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2019
• Device Catalogue Number: IAS12-100LPI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2016
• 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
• Patient Outcome(s): Life Threatening
• Patient Age: 59 YR