(b)(4).Date sent: 1/5/2024 d4: batch # unk an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.Additional information was requested and the following was obtained: did the device staple? -yes if so, did the device deploy the whole staple line? -yes if so, were the staples the appropriate b-shape form? -yes what device was used with the reported cartridge? -psee45a was the device stapled on normal lung tissue or emphysematous? - normal lung tissue.
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It was reported that during a thoracoscopic right pulmonary bullectomy, the operation went smoothly.No obvious bleeding at the resection margin was found during the operation.The chest drainage was increased on the 2nd day after the operation.On october 6, re-examination of chest x-ray and chest ct showed increased hemothorax on the right side and poor patency of chest tube drainage.It was considered to have postoperative intrathoracic hemorrhage with blood clots blocking the chest tube.The patient was given intrapleural injection of urokinase and ecg monitoring.230ml bloody fluid could be extracted from the chest tube.Reexamination of blood routine showed hemoglobin concentration 74 (g/l) , which was considered to be caused by intrathoracic hemorrhage.On october 8, red blood cells 2u and fresh frozen plasma 200ml were infused.Later re-examination of chest x-ray showed decreased pleural effusion on the right side and the right chest tube was removed on (b)(6), the patient had high fever, with the highest body temperature of 39.0, occasional chest tightness.The re-examination showed infection indicators increased.The anti-infective treatment was continued.The re-examination of chest ct suggested right intrathoracic effusion.On (b)(6), the patient was given ultrasound-guided closed thoracic drainage.After the operation, reddish fluid was extracted and the chest tightness was relieved.On (b)(6) the right thoracic drainage was removed.No additional information can be provided.
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