da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER A DA VINCI HYSTERECTOMY PROCEDURE, DURING THE CYSTOSCOPY, IT WAS FOUND THAT THE PATIENT'S URETER HAD BEEN DAMAGED. THE URETER WAS REPAIRED VIA A URETERONEOCYSTOTOMY PROCEDURE, AND THE PATIENT WAS DISCHARGED TWO DAYS LATER. NO ADDITIONAL PATIENT HARM OR ADVERSE OUTCOME WAS REPORTED.

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 8 DAYS AFTER A DA VINCI S HYSTERECTOMY PROCEDURE, THE PT UNDERWENT AN EXPLORATORY LAPAROSCOPY PROCEDURE WHERE A BOWEL PERFORATION WAS DISCOVERED. THE PERFORATION WAS REPAIRED, HOWEVER, THE PT BECAME SEPTIC DUE TO A BILIOUS FLUID LEAKAGE. THE PT WAS IN CRITICAL CARE FOR 2 WEEKS AND WAS THEN TRANSFERRED TO LONG TERM CARE. NO ADD'L PT HARM OR ADVERSE OUTCOME WAS REPORTED.

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 DURING A DA VINCI S BEATING HEART DOUBLE VESSEL CORONARY ARTERY BYPASS GRAFT PROCEDURE AT THE HOSPITAL, THERE WAS AN UNEXPLAINED MOVEMENT ON THE SYSTEM ARM WHICH HAD THE ENDOWRIST STABILIZER INSTRUMENT ATTACHED TO IT. THE UNEXPECTED MOVEMENT CAUSED THE FEET AT THE DISTAL END OF THE ENDOWRIST STABILIZER INSTRUMENT TO TIP DOWNWARD RESULTING IN DAMAGE TO THE MYOCARDIUM OF THE PATIENT'S LEFT VENTRICLE. THE SURGICAL TEAM IMMEDIATELY CONVERTED TO AN OPEN STERNOTOMY TO SUCCESSFULLY REPAIR THE DAMAGED VENTRICLE WITH A SINGLE MEDTRONIC U-CLIP S50. THE PATIENT WAS REPORTED AS RECOVERING WELL WITH NO POST-OPERATIVE COMPLICATIONS.

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 TOWARDS THE END OF A DA VINCI S GYNECOLOGIC DIAGNOSTIC LAPAROSCOPY PROCEDURE, THE ASSISTANT SURGEON PLACED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT INSIDE OF THE PT'S BODY AND WAS MOVING THE INSTRUMENT OUTSIDE OF THE FIELD OF VIEW. THE CONSOLE SURGEON TOOK CONTROL OF THE INSTRUMENT WITHOUT HAVING A VISUAL OF WHERE THE INSTRUMENT WAS LOCATED AND ACTIVATED THE INSTRUMENT TIP, WHICH CREATED A TRANSECTION CUT TO THE PT'S RIGHT INTERNAL ILIAC ARTERY AND RIGHT URETER. THE PROCEDURE WAS CONVERTED TO OPEN SURGICAL TECHNIQUES AND A VASCULAR SURGEON AND UROLOGIST WERE CALLED IN TO REPAIR THE PT'S RIGHT INTERNAL ILIAC ARTERY AND STENT THE URETER. A BLOOD TRANSFUSION WAS REQUIRED DURING THE REPAIR SURGERY. IT WAS REPORTED THAT THE PT IS RECOVERING AS PLANNED POST-OPERATIVE DAY 27.

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 7/11/08, ISI RECEIVED MEDWATCH REPORT, WHICH INDICATES THAT AN ADVERSE EVENT OCCURRED IN '08, DURING THE USE OF THE DA VINCI S SURGICAL SYSTEM AND A GYNECARE X-TRACT TISSUE MORCELLATOR IN A SURGICAL PROCEDURE. THE REPORT WAS SUBMITTED TO THE FDA BY THE PT, HOWEVER, A DESCRIPTION OF THE EVENT WAS NOT PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IN 2008, IT WAS REPORTED THAT THE SITE EXPERIENCED A SYSTEM FAULT WHILE SETTING UP FOR A DA VINCI S PROSTATECTOMY SURGICAL PROCEDURE. NO PT ISSUES WERE REPORTED AT THAT TIME. ON 7/3/08, ADDITIONAL INFO WAS RECEIVED FROM THE ATTENDING SURGEON WHO INDICATED THAT CONTINUOUS SYSTEM FAULTS OCCURRED AFTER THE PT PORTS WERE PLACED, RESULTING IN A 1 HOUR DELAY. DURING THE DELAY, THE PT'S ABDOMEN BECAME DEFLATED AND THE PT BUCKED VERTICALLY. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER VIA TELEPHONE, THE SYSTEM FAULTS WERE RESOLVED BY CLEANING THE FIBEROPTIC CABLE AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. THE PT RETURNED TO THE OPERATING ROOM THREE DAYS AFTER THE PROCEDURE WAS PERFORMED WITH THE SYSTEM AND A SMALL BOWEL LACERATION WAS DISCOVERED AND REPAIRED. IT IS BELIEVED THAT THE SMALL BOWEL LACERATION WAS CAUSED AT SOME POINT IN THE PROCEDURE ON 4/1/08, WHEN THE INJURED AREA OF THE BOWEL WAS NOT IN VIEW. THIS COULD HAVE OCCURRED DURING INITIAL PLACEMENT OF THE SURGICAL PORTS, WHEN THE PT BUCKED ON THE TABLE AND THE TROCARS WERE STILL INSTALLED DURING THE SYSTEM DELAY, DURING MANIPULATION OF THE BOWEL, OR DURING AN UNOBSERVED INSERTION OF A DA VINCI S OR ASSISTANT INS