Catalog Number IAS12-100LPI |
Device Problems
Unintended Collision (1429); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Date of event was reported as (b)(6) 2018, exact date is unknown.At time of filing, the reported device is not expected to be returned to conmed for evaluation.This reported event is entering the investigation process.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.
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Event Description
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It was reported by medical staff that they had knowledge of previous incidents involving the ias12-100lpi, airseal 12/100mm lpi port.They reported the " needle (sh-1 (j&j) got stuck in trocar.The needle got stuck the edge of the trocar but was not lost." event occurred at (b)(6) hospital in (b)(6) 2018, exact date unknown during a robot assisted urology surgery.It was indicated that there was no known impact or injury to the patient, and to conmed's knowledge the procedure was successfully completed.No further information is available.This report is being raised on the basis of previous us fda mdr reporting of similar malfunction with potential for injury upon reoccurrence.
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Manufacturer Narrative
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H11; correction made to address and zip code listed for manufacturer, correction listed in d3 and g2.H10: the device will not be returned for evaluation and no photographic evidence was provided therefore root cause cannot be identified.As a lot number was not provided, conmed could not conduct a two-year lot history review or review the manufacturing documents from the device history record.(b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.The ifu also advises the user 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.A determination for further investigation has been initiated.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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