MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT 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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

Additional fda product code: gcj.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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the ias12-100lpi device was being used during a robot-assisted prostatectomy on (b)(6) 2021 when it was reported that "a needle count just before the end of the surgery showed that one needle was missing, and after a search, an x-ray confirmed that it was inside the trocar." the procedure was completed without an alternate device.There was no impact/injury to the patient.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

The reported event of "needle found inside trocar" is confirmed.The device will not be returned for evaluation however the provided photographic evidence exhibits the reported event.A 2 year lot history review could not be conducted as a lot number was not provided.A dhr review could not be conducted as a lot number was not provided.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.During this same time frame 817,362 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 0.000007.Per the instructions for use, the user is advised the following: 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.This issue will continue to be monitored through the complaint system to assure patient safety.

Manufacturer Narrative

Additional information: the reported event of "needle found inside trocar" is confirmed based upon the photographic evidence provided by the facility; however, evaluation of the returned device could not confirm the reported event.The lab received one ias12-100lpi in unoriginal packaging.Lot number was not verified.Performed a visual inspection, device came fully assembled.There were no obvious signs of abnormalities or defects.When device was pulled apart there were no obvious signs of abnormalities or defects as well.Performed a functional inspection using the airseal i.F.S, the device functioned as intended and was able to maintain pneumoperitoneum.It appears that the needle became dislodged during handling and was lost during shipping.

• 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: 11398165
• MDR Text Key: 246658045
• Report Number: 3007305485-2021-00100
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K190303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAS12-100LPI
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Date Manufacturer Received: 05/27/2021
• Patient Sequence Number: 1
• Treatment: ETHICON NEEDLE, 3-0 VICRYL, J305, RB-1.