MAUDE Adverse Event Report: CONMED CHIHUAHUA AIRSEAL 12/100MM LPI PORT; INSUFFLATOR, LAPAROSCOPIC

Model Number IAS12-100LPI

Device Problems Crack (1135); Material Fragmentation (1261)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/25/2021

Event Type  malfunction  

Manufacturer Narrative

Note: this report is being resubmitted following an unsuccessful submission attempt on (b)(6) 2021 due to a system error.Additional product code: gcj.The reported device has been returned to conmed; however, the investigation of the device has not been completed.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

Further assessment has been sent; however, to date no response has been received.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.Ddrum (b)(6) 2021 it was reported by conmed (b)(6) on behalf of their customer that ¿during surgery the ias12-100lpi airseal 12/100mm lpi port has a crack observed on the tip of the trocar (when package was opened).Inserted into patient once; however, immediately replaced with a new one.The surgery was completed with an alternate same device.There was no indication patient or user injury reported.

Event Description

Update: information received from conmed japan on 28sep21 indicates that no fragments of the device remain in the patient.Therefore, this complaint status is updated to malfunction with potential for injury upon reoccurrence.Update: device evaluation revealed a piece was missing from the trocar.Assessment was sent to confirm the piece was retrieved; however, no information has been received to date.Therefore, this complaint status was changed to injury due to not knowing if the missing piece of trocar remains in patient.Update: conmed japan is filing to the pharmaceuticals and medical device aurthority; therefore, conmed will file.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.Ddrum (b)(6) 2021 it was reported by conmed japan on behalf of their customer that ¿during surgery the ias12-100lpi airseal 12/100mm lpi port has a crack observed on the tip of the trocar (when package was opened).Inserted into patient once; however, immediately replaced with a new one.The surgery was completed with an alternate same device.There was no indication patient or user injury reported.

Manufacturer Narrative

Update: information received from conmed japan on 28sep21 indicates that no fragments of the device remain in the patient.Therefore, this complaint status is updated from injury to malfunction with potential for injury upon reoccurrence.Manufacturer report: a visual inspection was performed and the blue sound reduction duck bill was torn on one side and detached from the sound reduction cap.The visual inspection did not find a crack on the tip of the trocar; however, the serrated cannula was inspected and a part of the interior of the cannula was broken and the broken piece could not be found.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.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 20 complaints, regarding (b)(4) 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: failure to properly follow the instructions for use can lead to serious surgical consequences.Use extreme caution during airseal access port insertion.Improper use of this product can result in life-threatening injury to internal organs and vessels.This issue will continue to be monitored through the complaint system to assure patient safety.

Manufacturer Narrative

A visual inspection was performed and the blue sound reduction duck bill was torn on one side and detached from the sound reduction cap.The visual inspection did not find a crack on the tip of the trocar; however, the serrated cannula was inspected and a part of the interior of the cannula was broken and the broken piece could not be found.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.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 20 complaints, regarding 21 devices, for this device family and failure mode.During this same time frame 862,950 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: failure to properly follow the instructions for use can lead to serious surgical consequences.Use extreme caution during airseal access port insertion.Improper use of this product can result in life-threatening injury to internal organs and vessels.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

Update: device evaluation revealed a piece was missing from the trocar.Assessment was sent to confirm the piece was retrieved; however, no information has been received to date.Therefore, this complaint status was changed to injury due to not knowing if the missing piece of trocar remains in patient.Update: conmed japan is filing to the pharmaceuticals and medical device aurthority; therefore, conmed will file.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.Ddrum 2aug21 it was reported by conmed japan on behalf of their customer that ¿during surgery the ias12-100lpi airseal 12/100mm lpi port has a crack observed on the tip of the trocar (when package was opened).Inserted into patient once; however, immediately replaced with a new one.The surgery was completed with an alternate same device.There was no indication patient or user injury reported.

• Brand Name: AIRSEAL 12/100MM LPI PORT
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): CONMED CHIHUAHUA; alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• MDR Report Key: 12385713
• MDR Text Key: 268733313
• Report Number: 3007305485-2021-00331
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 10845854045640
• UDI-Public: (01)10845854045640(17)240205(10)202102055
• 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: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2024
• Device Model Number: IAS12-100LPI
• Device Catalogue Number: IAS12-100LPI
• Device Lot Number: 202102055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Date Manufacturer Received: 09/28/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other