Tested with prerelease Houdini FX 19.0.524 using a narrow band FLIP simulation scene.
MAC MACLOC PC
16-core PC desktop CPU performance data from testing Core i9-12900K with DDR5 memory. 10-core PC desktop CPU performance data from testing Core i5-12600K with DDR5 memory. Performance measured using select industry‑standard benchmarks. Therefore, the conclusion of quality engineering risk assessment, that no further mitigating action is necessary at this time, is still valid.Have a question? Call a Specialist or chat online. The addition of this complaint would not change the conclusion of the risk assessment. We will continue to monitor for similar complaints and have notified the appropriate personnel. " per specification, quality control personnel inspects for suture security and functionality and ensures the curve is able to be opened and closed and that the mac-loc is functional.Īlthough we do not indicate cutting of the catheter or suture as a means of removal, if this is done, one of the exposed ends of the locking suture must be secured in order to prevent possible loss of the suture from the device. Pry upward until the locking cam lever is free. The ifu states, "while stabilizing the mac-loc catheter hub assembly with one hand, position a small, blunt object (approximately the shape and size of a ball point pen or small forceps) into the mac-loc release notch.
The instructions for use gives instructions on proper placement and removal of the catheter. The complainant did not report any adverse effects on the patient due to this occurrence.Īlthough requested, no product or images were returned to assist in our investigation. No part of the device remained inside the patient and the patient did not require additional procedures due to this occurrence. The doctor left the suture string in the body for 4 hours when he decided to pull a bit harder and the suture string came out of the body. The doctor cut off the locking mechanism and after pulling, the catheter came out, but the internal suture string of the drain stayed behind in the body as it was fixed and the doctor couldn't get it out.
MAC MACLOC UPDATE
Update as per received complaint form march 12, 2012: the doctor wanted to remove the drain, but the drain was fixed. No additional information has been provided by the reporter. The catheter came out, but the string stayed in the body of the patient. He decided to cut off a bit of the locking mechanism. The initial information provided to the manufacturer stated that the doctor tried to change a drainage catheter but was not able to pull the catheter out, because it was fixed.
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