MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT AIRSEAL 12/100MM LPI PORT; INSUFFLATOR, LAPAROSCOPIC

Catalog Number IAS12-100LPI

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2021

Event Type  malfunction  

Manufacturer Narrative

The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.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

The customer reported that the device, ias12-100lpi, was being used during a partial laparoscopic resection of the liver procedure on (b)(6) 2021 when "the airseal trocar was inserted into the patient body.After the airseal trocar was inserted into the patient body, the surgeon found out that the obturator cannot be removed from the inner cannula.The airseal trocar was removed from the patient body.A new airseal trocar was used and the surgery could be completed with it." the procedure was completed with an alternate same device.There was a 5 minute delay.There was no report of patient injury or impact.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The reported event of "obturator could not be removed from the inner cannula" is inconclusive.The device will not be returned for evaluation and no photographic evidence was provided therefore root cause cannot be identified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.(b)(4).Per the instructions for use, the user is advised the following: ensure that the obturator and cannula are properly assembled.Remove the obturator from the cannula, when prompted on the airseal ifs touch screen, by squeezing the cannula latch buttons to unlock the two devices.Note: the blunt tip does not have latch buttons so it can be removed by pulling the obturator straight out of the cannula.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): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• MDR Report Key: 11580896
• MDR Text Key: 242709150
• Report Number: 3007305485-2021-00148
• 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: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2023
• Device Catalogue Number: IAS12-100LPI
• Device Lot Number: 202011105
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2021
• Patient Sequence Number: 1