MAUDE Adverse Event Report: CONMED CORPORATION AIRSEAL 5/120MM PORT; AIRSEAL TROCAR

Catalog Number IAS5-120LP

Device Problem Fracture (1260)

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

Event Type  malfunction  

Manufacturer Narrative

The reported 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.

Event Description

The conmed sales representative reported on behalf of the user facility that during a procedure the ias5-120lp cannula cracked down the middle.The procedure was completed with no reported surgical delays.No patient injury was reported.This report is being raised on the basis of a reported malfunction with potential for injury with recurrence.

Manufacturer Narrative

Although multiple attempts were made, no information regarding the patient status or procedure was made available.The device was not returned for evaluation and no photographic evidence has been provided; therefore, the reported failure could not be verified and a root cause cannot be determined.A review of manufacturing documents was not possible as the lot number for this product was not made available.A two-year review of complaint history revealed 22 other adverse events for this product family and failure mode.During this same time frame, (b)(4) devices have been manufactured and shipped worldwide, making the rate of occurrence of this failure 0.003 percent, if all complaints were confirmed.The instructions for use advises the user of the following.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.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: AIRSEAL 5/120MM PORT
• Type of Device: AIRSEAL TROCAR
• Manufacturer (Section D): CONMED CORPORATION; 488 wheelers farms road; mildford CT 06461
• MDR Report Key: 7549426
• MDR Text Key: 109908323
• Report Number: 3006217371-2018-00135
• Device Sequence Number: 1
• Product Code: HIF
• 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,other
• Type of Report: Initial,Followup
• Report Date: 07/10/2018

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: IAS5-120LP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/01/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 07/09/2018
• Supplement Dates FDA Received: 07/10/2018
• Patient Sequence Number: 1