Based on the information provided, isi has not determined the root causes for the alleged post-operative complications experienced by the patient and her subsequent demise.The following information is unknown: what specific operative damages the patient sustained, and what the root causes were for the alleged operative damages, cardiopulmonary failure, post-operative bleeding, and death.In addition, the name of the facility where the da vinci-assisted surgical procedure was performed is unknown.Likewise, the name of the surgeon who performed the surgical procedure is unknown.If additional information is received a follow-up mdr will be submitted to the fda.No previous complaint was reported relating to this event.This complaint is being reported due to the following conclusion: the plaintiff's attorney claims that the patient underwent a da vinci-assisted surgical procedure, sustained unspecified damages, experienced post-operative complications, and subsequently expired.However, at this time, the root causes of the alleged operative complications are unknown.
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As part of a legal dispute, intuitive surgical, inc.(isi) received information regarding a patient who underwent a da vinci-assisted hysterectomy procedure on (b)(6) 2015 and allegedly sustained unspecified damages.The plaintiff's attorney claimed that immediately following surgery, the patient developed a cardiopulmonary failure and suffered from bleeding which led to her death.Isi was not provided with the operative report or any of the patient's medical records.
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