It was reported that the patient had a linx implanted on (b)(6) 2019, due to gerd.At the time of the procedure, the patient has a bowel perforation, which was unrecognized at the time of the procedure.It wasn't known if the patient stayed in the hospital for observation or was discharged.The patient returned, post op, with bowel leakage and infection.The doctor performed an explant on (b)(6) 2019, to remove the linx device, as a precautionary measure, so as not to introduce an additional foreign body in the patient, while the bowel perforation was resolved and healed.
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(b)(4).Additional information was requested, and the following was received: does the surgeon believe that the bowel perforation was not related to the linx device? correct! the surgeon said the bowel perforation was not related to the linx device.He believes the bowel perforation occurred on initial entry into the abdomen with the trocar.This was a robotic hiatal hernia repair with linx.The trocars that were used in the case were competitive trocars.H10: corrected data: upon review of the information received, it was concluded that this event does not meet the defined criteria for a reportable event and will be considered not reportable.H1: mdr decision ¿ not reportable.
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