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

Catalog Number IAS12-100LPI

Device Problems Unintended Collision (1429); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event was reported as (b)(6) 2018, exact date is unknown.At time of filing, the reported device is not expected to be returned to conmed for evaluation.This reported event is entering the investigation process.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

It was reported by medical staff that they had knowledge of previous incidents involving the ias12-100lpi, airseal 12/100mm lpi port.They reported the " needle (sh-1 (j&j) got stuck in trocar.While removing the suture/needle from the patient's body after placing the sutures the needle got stuck in the trocar.The needle was found inside the trocar by a camera." event occurred at (b)(6) hospital, (b)(6) during a laparoscopic hysterectomy in (b)(6) 2018, exact date unknown.It was indicated that there was no known impact or injury to the patient, and to conmed's knowledge the procedure was successfully completed.No further information is available.This report is being raised on the basis of previous us fda mdr reporting of similar malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

H11; correction made to address and zip code listed for manufacturer, correction listed in d3 and g2.The device will not be returned for evaluation and no photographic evidence was provided therefore root cause cannot be identified.As a lot number was not provided, conmed could not conduct a two-year lot history review or review the manufacturing documents from the device history record.A two-year review of complaint history revealed there has been a total of 5 complaints, regarding 6 devices, for this device family and failure mode.(b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.The ifu also advises the user failure to properly follow the instructions for use can lead to serious surgical consequences.Only qualified physicians with knowledge, experience and training in laparoscopic technique should use the components of the airseal access system.A determination for further investigation has been initiated.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; po box 11050; waterbury CT 06703
• MDR Report Key: 8905998
• MDR Text Key: 163301720
• Report Number: 1320894-2019-00298
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAS12-100LPI
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2019
• Patient Sequence Number: 1