Complaint is inconclusive.The device is not being returned and no photograph evidence was provided.Therefore, the reported failure could not be verified.The service history was reviewed and no data was found.The device history record was not reviewed, as the device is not manufactured by conmed.A two-year review of complaint history revealed there has been 4 complaints regarding (b)(4) devices for this device family and failure mode.During the same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following; to use extreme caution during airseal access port insertion.Improper use of this product can result in life-threatening injury to internal organs and vessels.Ensure that adequate pneumoperitoneum or pneumorectum is established.Ensure that the patient is properly positioned so that organs are away from the penetration site.Direct the airseal access port's tip away from significant vessels and organs.Do not use excessive downward force.Once a safe and proper entry has been achieved, ensure that the black like at the distal tip of the airseal access port is visible within the cavity at all times the airseal access port is being used for insufflation.This issue will continue to be monitored through the complaint system to assure patient safety.
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The conmed representative reported on behalf of the facility that the as-ifs1, airseal unit, caused subcutaneous emphysema after a laparoscopic nissen.The subcutaneous emphysema resolved post-surgery 24-48 hours later.This report is being raised due to patient injury.
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