da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AT THE END OF A DA VINCI HYSTERECTOMY SURGICAL PROCEDURE THE SURGICAL STAFF NOTICED A "DRIED OR BURN-LIKE" AREA AROUND THE CAMERA PORT INCISION, APPROX 2MM IN WIDTH. THE DAMAGED SKIN HAD TO BE CUFF OFF IN ORDER TO CLOSE THE INCISION. NO VISUAL DAMAGE NOR SIGNS OF MELTING WERE OBSERVED ON THE CANNULA ACCESSORY USED IN CONJUNCTION WITH THE CAMERA.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 04/08/2010, ISI RECEIVED VOLUNTARY MEDWATCH (B)(4) FROM THE FDA DEPARTMENT OF HEALTH AND HUMAN SERVICES REPORTING THE FOLLOWING: VOLUN 01-FEB-2010: MY NAME IS (B)(6). I AM THE PERSONAL REP OF THE ESTATE OF (B)(6), ON (B)(6) 2007, MY MOTHER HAD A DAVINCI ROBOT ASSISTED LAPAROSCOPIC HYSTERECTOMY AT (B)(6) MEDICAL CENTER IN (B)(6). IT IS MY UNDERSTANDING THAT DURING THIS EVENT, DR (B)(6) LOST VISUALIZATION AND THE INSTRUMENT ON THE ROBOT CUT THE RIGHT COMMON ILIAC ARTERY LEADING TO HEMORRHAGE, CARDIOPULONARY ARREST AND NEAR EXSAGUINATION. THE INFO I HAVE BEEN PROVIDED WITH INDICATES THAT THIS MAY HAVE BEEN REPORTED TO THE FDA AS A MAUDE ADVERSE EVENT ASSOCIATED WITH THE DAVINCI SURGICAL ROBOT. I HAVE NOT BEEN ABLE TO LOCATE SUCH A REPORT DURING MY ONLINE SEARCH. PHYSICIAN: (B)(6) MD. FACILITY: (B)(6) MEDICAL CENTER. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED, INCLUDING INFORMATION RELATED TO THE FIELDS IN (B)(6).

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON MARCH 12, 2010, ISI RECEIVED MAUDE EVENT REPORT (B) (4) WITH THE FOLLOWING EVENT DESCRIPTION: MY NAME IS XXX. I AM THE PERSONAL REP OF THE ESTATE OF XXX ON XX XX 2007, MY MOTHER HAS A DA VINCI ROBOT ASSISTED LAPAROSCOPIC HYSTERECTOMY AT XXX MEDICAL CENTER IN XXX. IT IS MY UNDERSTANDING THAT DURING THIS EVENT DR XXX LOST VISUALIZATION AND THE INSTRUMENT ON THE ROBOT CUT THE RIGHT COMMON ILIAC ARTERY LEADING TO HEMORRHAGE, CARDIOPULMONARY ARREST AND NEAR EXSANGUINATION. THE INFO I HAVE BEEN PROVIDED WITH INDICATES THAT THIS MAY HAVE BEEN REPORTED TO THE FDA AS AN MAUDE ADVERSE EVENT ASSOCIATED WITH THE DA VINCI SURGICAL ROBOT. I HAVE NOT BEEN ABLE TO LOCATE SUCH A REPORT DURING MY ONLINE SEARCH. PHYSICIAN XXX. MEDICAL FACILITY XXX. NO ADDITIONAL INFORMATION WAS PROVIDED.