MAUDE Adverse Event Report: SEQUEL SPECIAL PRODUCTS AIRSEAL TROCAR; INSUFFLATOR, LAPAROSCOPIC

Catalog Number IAS8-120LP

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2018

Event Type  malfunction  

Manufacturer Narrative

Device was received in opened unoriginal packaging, the reported catalog number was verified, the lot number was not verified.Inspection found that the sound reduction duckbill had detached form the sound reduction cap.There was no obvious damage to the duckbill component.Inspection found that the foam component of the sound reduction cap was pushed to one side.A two-year review of complaint history revealed there has been a total of 12 complaints, regarding 12 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 0.00002.Per the instructions for use, the user is advised the following: precautions: inspect sound cap blue foam and blue seal prior to use, use caution when inserting a sharp or large device through the cannula, inspect the sound cap after use for physical damage of any kind.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported that ias8-120lp, airseal 8mm access port and low profile obturator with bladeless optical tip, 120mm length, qty 6, device seal came off and fell into the patient during a procedure on (b)(6) 2018.The doctor recovered the seal and made sure all components were removed.There was no report of delay of procedure or any injury to the patient/user.Further information has been requested of the account; however, the account has stated that no one is aware of this incident.No further information has been made available to date.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: AIRSEAL TROCAR
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): SEQUEL SPECIAL PRODUCTS; 1 hillside dr; wolcott CT 06716
• Manufacturer (Section G): SEQUEL SPECIAL PRODUCTS; 1 hillside dr; wolcott CT 06716
• Manufacturer Contact: john berga ; 11311 concept blvd.; largo, FL 33773 ; 7273995358
• MDR Report Key: 8069614
• MDR Text Key: 129161734
• Report Number: 3006217371-2018-00253
• Device Sequence Number: 1
• Product Code: HIF
• 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,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAS8-120LP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Date Manufacturer Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1