(b)(4).Batch # m55g9h.Additional information was requested and the following was obtained: linear stapler was attached to a stronger vessel, closed, shot down.Once opened, vessel was not stapled but cut.Massive hemorrhage, which has been trying to stop.The patient became a heart attack or atrial fibrillation.Heart specialists were called, without success.Retrospectively, they became known that the patient was cardiac.What were the indications for surgery? lung cancer (left upper lobe).Did the issue occur on the first firing? if not how many times was the device reloaded? yes.The device was never reloaded at all.After the device was closed was the device cut with a scalpel? no.Was there any precaution taken to provide proximal and distal control prior to stapling/cutting? yes.Following our standard procedure two threads were passed around the lower circumference of the vessel exposed for suturing ¿ one thread guided towards the periphery, one towards the central part of the artery.Both threads immediately came loose when the continuity of the vessel was destroyed after the staples had been fired.If the device was fired, were staples present and what was their form? please describe.Not possible.There was a profuse bleeding directing our focus elsewhere.What an autopsy conducted and, if so, are the results available? yes.The results have not been communicated to us.Is the surgeon willing to speak with the ethicon medical director and engineering? there is a multilingual director available to speak with surgeon.Contact the surgeon directly.The analysis results showed that the tx30v device arrived in good visual condition and with a reload loaded on the device.The reload was received fully loaded with staples.The device was tested for functionality with the returned reload and it fired and formed all the staples as intended.The device fired without any difficulties, the staples were noted to have a proper b-formation and the staple line was complete.A batch record review was performed and no anomalies were found during the manufacturing process.
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It was reported that during the suturing of a large (approx.8mm in diameter) pulmonary artery branch to the lingula procedure, "when settle the pulmonary artery," the staples have cut the vessel.Blood flow could not be stopped.The patient died on the operating table.
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(b)(4).Additional information was requested and the following was obtained: the device was returned with a cartridge full of staples and no evidence of firing.When was the bleeding identified: after firing the device; upon closure, upon attempted firing or upon opening: upon opening; does the surgeon use multiple brands and what is his/her experience with the device: surgeon is a senior professor, has more than 20 years of experience with all types of brands; does the surgeon typically open and inspect the staple line prior to transection: yes; as this device does not have a knife, why does the surgeon believe the device cut: the surgeon never thought that the device would cut.Nevertheless there was immediate severe bleeding upon opening the device after firing ¿ somehow the vessel had been neatly severed.
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