Isi has made multiple attempts to contact the physician (initial reporter) at (b)(6), for additional information concerning the reported event, however, no additional information has been provided.
If additional information is received a follow-up mdr will be sent to the fda.
At this time, there has been no report by the site that during the planned surgical procedure that a malfunction of the da vinci si system, instruments and/or accessories occurred.
It was reported that during a da vinci si bilateral salpingo-oophorectomy procedure, during placement of the uterine manipulator, the patient's bowel was ruptured.
The surgeon repaired the patient's bowel, which took approximately 3 hours to repair.
Two days post op the patient experienced cardiovascular complications and complications and expired.
The surgeon is attributing the patient's demise to a t-berg.
No other information was provided.