In the journal of medicine, st.Hamamatsu hospital, volume 23, issue 2 it was reported: a case of robot-assisted partial nephrectomy with gas embolis during surgery.It was reported that, ¿a case of robot-assisted partial nephrectomy in which gas embolism occurred during surgery¿.There was no report of the as-ifs1 having a malfunction.This report is being raised due to the reported injury of gas embolism.
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The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.The service history review cannot be conducted as a serial number was not provided.A device history record (dhr) review cannot be conducted as a serial number was not provided.A two-year review of complaint history revealed there has been a total of 12 reports, regarding 13 devices, for this device family and failure mode.During this same time frame 1,224,402 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 0.00001.Per the instructions for use, the user is advised the following: improper placement of the insufflation instrument could cause gas penetrating a vessel or an internal organ, resulting in gas embolisms.To reduce the 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.We will continue to monitor for trends through the complaint system to assure patient safety.
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