MAUDE Adverse Event Report: SEQUEL SPECIAL PRODUCTS AIRSEAL 12/100MM LPI PORT; INSUFFLATOR, LAPAROSCOPIC

Catalog Number IAS12-100LPI

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2018

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

This distributor reported that the ias12-100lpi, airseal 12mm access port and palm grip obturator with bladeless optical tip, 100mm length, qty 6, device's sound cap would not stay in place on the device.There was no report of any component falling into the surgical site; therefore, no retrieval was required.It is unclear if this took place before or during usage of the device; however, the device was in the sterile field at the time of the event.The reporter has stated that this took place during a robot-assisted laparoscopic prostatectomy on (b)(6) 2018.The event caused a 3-minute delay in the procedure.The procedure was completed successfully using another same device type.The reporter has stated that there was no injury to the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

To date, the reported device has not been returned to conmed for evaluation.Should the device be returned an evaluation will be performed.Upon completion of the complaint investigation a supplemental and final report will be filed.Otherwise this filing will stand as the final report.A two-year review of complaint history revealed there has been a total of 19 complaints, regarding 29 devices, for this device family and failure mode.During this same time frame 15,952 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.002.Per the instructions for use, the user is advised the following: - if desired, optional sound cap may be placed on cannula at this time.(note: if using optional sound cap, use caution when inserting a sharp or large device through the cannula.The optional sound cap may be removed from the cannula at any time during the procedure.) this issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: AIRSEAL 12/100MM LPI PORT
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): SEQUEL SPECIAL PRODUCTS; 122 avenue of industry; waterbury CT 06705
• MDR Report Key: 7557786
• MDR Text Key: 109773607
• Report Number: 1320894-2018-00134
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: IAS12-100LPI
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2018
• Patient Sequence Number: 1