Conmed (b)(4) reported on behalf of their customer that the as-ifs1, airseal unit was used in a laparoscopic partial hepatectomy on unknown date, where the patient had a hole in the hepatic artery.The air seal pressure setting was 8mmhg.The doctor closed since the patient saturation has been decreased and found out there was a hole on hepatic artery.After the closing the hole the saturation was improved.After the 2 to 3 days from the surgery a deep vein thrombotic symptom has been observed.The doctor commended there is no evidence that this symptom has causal relationship to air seal.There is no indication that the airseal unit malfunctioned in any way.There is no actual complaint against the airseal, just that it was used in this procedure.Additional information and investigation has been requested but to date has not been received.As this was reported to the (b)(6) by conmed (b)(4), we are filing to the fda.
|
The device will not be returned for evaluation and no photographic evidence was provided therefore root cause cannot be identified.Additionally, there is no reported allegation of device malfunction.The service history was reviewed, and no data was found.As the device has been in the field for more than 12 months, the dhr was not reviewed.(b)(4).Per the instructions for use, the user is advised the following; insufflation of co2 should be done carefully and while monitoring the patient's response.The user, particularly the anesthetist, should be informed about possible cardiovascular and respiratory problems of the patient and monitor these intra-operatively.Improper placement of the insufflation instrument could cause gas penetrating a vessel or an integral organ, resulting in gas embolisms.To reduce this risk, use a low flow rate for the first insufflation and ensure that the insufflation instrument is correctly positioned.Check the position of the insufflation instrument immediately if the actual pressure rapidly reaches the nominal pressure value.Gas embolisms can also be caused by a high intra-abdominal pressure.Avoid high pressure settings and close damaged blood vessels at once.Additionally, conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected.This issue will continue to be monitored through the complaint system to assure patient safety.
|