Catalog Number IAS12-100LPI |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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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.
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Event Description
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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.
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Manufacturer Narrative
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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.
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Event Description
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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.
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Manufacturer Narrative
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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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Search Alerts/Recalls
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