The conmed sales representative reported that during a sacrocolpopexy procedure, during smoke evacuation with the use of sem-evac, the patient suffered of subcutaneous emphysema.The procedure was completed with no reported surgical delays.To date, no additional information regarding the patient status or procedure has been made available.This report is raised on the basis of a reported patient injury.
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The device was not returned by the user facility and no photographic evidence was provided; therefore, the reported failure could not be verified and a root cause cannot be conclusively determined.Although multiple attempts have been made, no additional information regarding the patient status, procedure or need for additional treatment has been made available.The concomitant devices, as-ifs1, were tested and met pressure accuracy specifications.A review of manufacturing documents was not possible as the lot number for this product was not made available.A two-year review of complaint history revealed 2 similar complaints for this product family and failure mode.In that same timeframe, (b)(4) of this product family have been sold worldwide, making the rate of occurrence of this failure (b)(4) percent, if all complaints were confirmed.The instructions for use advises the user of 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 techniques should use the components of the airseal access system.- higher insufflation pressures (> 15 mm hg) of carbon dioxide can increase the risk of hypercarbia, subcutaneous emphysema, pneumomediastinum, pneumothorax, pneumoscrotum and urinary retention.This issue will continue to be monitored through the complaint system to assure patient safety.
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