The reported product is an unknown baxter flo-rester vessel occluder.The device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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It was reported from an anonymous survey result that the potential response risk with the use of a flo-rester vessel occluder when used to internally occlude blood vessels during anastomosis procedures was rated as moderate for risk of endothelial erosion (resulting in embolization).The physician reported ¿trauma to endothelium¿ (no further details).At the time of this report, no further detail was provided regarding if hospitalization was required, treatment for the event or the patient¿s outcome.No additional information is available.
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