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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED CHIHUAHUA AIRSEAL 12/100MM LPI PORT; INSUFFLATOR, LAPAROSCOPIC
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CONMED CHIHUAHUA AIRSEAL 12/100MM LPI PORT; INSUFFLATOR, LAPAROSCOPIC Back to Search Results
Catalog Number IAS12-100LPI
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
Additional fda product code: gcj manufacturer narrative: the reported device has been returned to conmed; however, the evaluation 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.
 
Event Description
Conmed japan reported on behalf of the customer that during a thoracic procedure on (b)(6) 2021 fragments from what is believed to be a ias12-100lpi trocar were discovered in the patient.These fragments were thought to be from a previous thoracic surgery the patient underwent two years ago.This broken piece could be the tip part of airseal trocar.The fragments were evaluated by conmed and it could not be determined that they were from a conmed device.The procedure was completed.Further assessment question have been sent, but to date no response has been received.This report is being raised on the basis of injury due to fragments left in patient.
 
Event Description
Conmed japan reported on behalf of the customer that during a thoracic procedure on (b)(6) 2021 fragments from what is believed to be a ias12-100lpi trocar were discovered in the patient.These fragments were thought to be from a previous thoracic surgery the patient underwent two years ago.This broken piece could be the tip part of airseal trocar.The fragments were evaluated by conmed and it could not be determined that they were from a conmed device.The procedure was completed.Further assessment question have been sent, but to date no response has been received.This report is being raised on the basis of injury due to fragments left in patient.
 
Manufacturer Narrative
The fragments were curved and serrated on one end.The returned fragments look very similar to parts of the serrated cannula of the ias12-100lpi.However, cannot confirm for certain this is a ias12-100lpi.A device history review could not be performed as a lot number was not provided.A 2 year lot history 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 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.Do not use excessive downward force.This issue will continue to be monitored through the complaint system to assure patient safety.
 
Event Description
Conmed japan reported on behalf of the customer that during a thoracic procedure on (b)(6) 2021 fragments from what is believed to be a ias12-100lpi trocar were discovered in the patient.These fragments were thought to be from a previous thoracic surgery the patient underwent two years ago.This broken piece could be the tip part of airseal trocar.The fragments were evaluated by conmed and it could not be determined that they were from a conmed device.The procedure was completed.Further assessment question have been sent, but to date no response has been received.Update: it is confirmed through further evaluation, the fragments were from a ias12-100lpi.This report is being raised on the basis of injury due to fragments left in patient.
 
Manufacturer Narrative
Correction: b5 was "conmed japan reported on behalf of the customer that during a thoracic procedure on (b)(6) 2021 fragments from what is believed to be a ias12-100lpi trocar were discovered in the patient.These fragments were thought to be from a previous thoracic surgery the patient underwent two years ago.This broken piece could be the tip part of airseal trocar.The fragments were evaluated by conmed and it could not be determined that they were from a conmed device.The procedure was completed.Further assessment question have been sent, but to date no response has been received." it was updated to "it is confirmed through further evaluation, the fragments were from a ias12-100lpi." h10 evaluation statement has been corrected from device ias12-100lpi cannot be confirmed to device was a ias12-100lpi.Manufacturer narrative: the fragments were curved and serrated on one end.The returned fragments look very similar to parts of the serrated cannula of the ias12-100lpi.However, cannot confirm for certain this is a ias12-100lpi.Update: the fragments returned were inspected and measurements of the serrations and the distance from end to first serration on the second fragment were taken.When inspecting the two fragments it was confirmed the fragments fitted together to create a portion of the trocar that broke off, the shape of the small vents at the end of the trocar was found on the fragments.When two pieces were fitted a portion of the vent was noted.Measurements of the vent were taken.Per drawing, the measurements are specifications of ias12-100lpi.A device history review could not be performed as a lot number was not provided.A 2 year lot history review could not be conducted as a lot number was not provided.This issue will continue to be monitored through the complaint system to assure patient safety.
 
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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 Key12385427
MDR Text Key268722024
Report Number3007305485-2021-00326
Device Sequence Number1
Product Code HIF
Combination Product (y/n)N
PMA/PMN Number
K143404
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 10/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberIAS12-100LPI
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2021
Initial Date Manufacturer Received 07/01/2021
Initial Date FDA Received08/30/2021
Supplement Dates Manufacturer Received08/20/2021
09/29/2021
Supplement Dates FDA Received09/13/2021
10/26/2021
Patient Sequence Number1
Patient Outcome(s) Other;
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