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

Catalog Number IAS12-100LPI

Device Problem Material Fragmentation (1261)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The alleged " blue rubber gasket or seal tear in half during a davinci assisted prostatectomy.The fragment was removed from the pelvis." occurring with a ias12-100lpi is not expected to be returned.This complaint is unable to be verified and the root cause cannot be determined.A two-year review of complaint history revealed there has been a total of 24 complaints, regarding 24 devices, for this device family and failure mode.During this same time frame (b)(4) 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 (b)(4).Per the instructions for use, the user is advised the following: general instructions: step 20 - 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 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.

Event Description

This complaint was created due to the receipt of a medwatch report (mw5077116) received from the fda on 21may2018.A search of the complaint system has not found a complaint reported by the user facility.The reporter of the medwatch did not disclose their facility name, address or contact phone number.No further information can be obtained on this event from the user facility.The ias12-100lpi, airseal 12 mm access port and palm grip obturator with bladeless optical tip, 100 mm length, qty 6, was reported as having the blue rubber gasket or seal tear in half during a davinci assisted prostatectomy.The fragment was removed from the pelvis per the medwatch report.Although the reporter of the medwatch indicated "serious injury" the reporter stated that the fragment was removed from the patient.There is no evidence of injury to patient or user in the reporter's statements.This reporting is being raised as a device malfunction with potential for injury upon reoccurrence.

• 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
• Manufacturer (Section G): SEQUEL SPECIAL PRODUCTS; 122 avenue of industry; waterbury CT 06705
• Manufacturer Contact: john berga ; 11311 concept blvd.; largo, FL 33773 ; 7273995358
• MDR Report Key: 7589101
• MDR Text Key: 110898406
• Report Number: 1320894-2018-00141
• 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: other
• Type of Report: Initial
• Report Date: 06/11/2018

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: Other
• Device Catalogue Number: IAS12-100LPI
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/21/2018
• Initial Date FDA Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1