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 (B)(6) 2016, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5061216 WITH THE FOLLOWING EVENT DESCRIPTION: UNDERWENT HYSTERECTOMY WITH DAVINCI ROBOT AND EXPERIENCED A 2 INCH LACERATION AT (B)(6) HOSPITAL IN (B)(6) PERFORMED BY DR. (B)(6). HIGH RISK FOR THIS PROCEDURE BECAUSE HAD A C-SECTION SEVERAL YEARS AGO. KEPT OVERNIGHT. QUESTION AS TO WHY DAVINCI ROBOT WAS USED WHEN POSSIBLY MORE DELICATE TECHNIQUE SHOULD HAVE BEEN USED RATHER THAN THE DAVINCI ROBOT.

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-ASSISTED TRANSORAL ROBOTIC (TORS) PROCEDURE, THE ARMS OF THE PATIENT SIDE CART (PSC) ALLEGEDLY MOVED ON THEIR OWN AS THE SURGEON GOT UP FROM THE SURGEON SIDE CONSOLE (SSC). ACCORDING TO THE INITIAL REPORTER, AS THE SURGEON REMOVED HIS HEAD FROM THE HIGH RESOLUTION STEREO VIEWER (HRSV), ARM 1 AND ARM 2 MOVED FROM A VERTICAL TO HORIZONTAL POSITION WITH INSTRUMENTS STILL INSTALLED ON BOTH ARMS. AS A RESULT, ONE OF THE INSTRUMENTS ALLEGEDLY INJURED THE PATIENT'S TONGUE. THERE WERE NO REPORTS OF ANY SYSTEM ERROR MESSAGES. AFTER THE EVENT OCCURRED, AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED FOR ASSISTANCE. THE TSE REVIEWED THE SITE'S SYSTEM LOGS AND VERIFIED THAT THERE WERE NO RELATED SYSTEM ERROR MESSAGES. THE TSE HAD THE INITIAL REPORTER MOVE THE ARMS WITHOUT PRESSING ANY OF THE CLUTCH BUTTONS. THE INITIAL REPORTER WAS ABLE TO MOVE THE ARMS WHICH RETURNED TO THE SOFT-LOCK POSITION AS EXPECTED. ON (B)(6) 2016, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE WAS UNABLE TO REPRODUCE THE CUSTOMER REPORTED ISSUES WITH THE ARMS OF THE PSC. THE FSE TESTED THE DA VINCI

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A CLINICAL LITERATURE REVIEW AN ARTICLE REFERENCED THAT POST A DA VINCI-ASSISTED MITRAL VALVE REPAIR PROCEDURE PERFORMED ON AN UNSPECIFIED DATE IN 2005, THE PATIENT PRESENTED TO A NEUROLOGIST IN 2009 WITH A HEADACHE. THE PATIENT HAD REPORTEDLY UNDERGOING CARDIAC CATHETERIZATION ON AN UNSPECIFIED DATE IN 2004. AN MRI OF THE PATIENT'S BRAIN SHOWED MULTIPLE MICRO-HEMORRHAGES. A CT-SCAN OF THE PATIENT'S HEAD WAS NEGATIVE. AN MRI PERFORMED IN 2003 DID NOT DEMONSTRATE ANY OF THE LESIONS. THE NEUROLOGIST PRESUMED THAT THE MRI FINDINGS WERE RELATED TO METALLIC MICRO-EMBOLI INSTEAD OF MICRO-HEMORRHAGES. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING AN SEEG SURGERY, ELECTRODE INACCURACIES WERE OBSERVED. THE SURGEON ALSO REPORTED THAT THE PATIENT SUFFERED A SMALL SUBARACHNOID HEMORRHAGE. THE SURGEON REPORTED THAT DURING THE SURGERY THE DRILL BITS WERE GETTING STUCK IN THE DRILL ADAPTOR. THE SURGEON ALSO REPORTED THAT HEAD SHIFT OCCURRED WHILE PLACING BOLTS ON THE RIGHT SIDE. A FOLLOW UP CT THE DAY AFTER SURGERY SHOWED THAT THE HEMORRHAGE HAD RESOLVED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE HAS BEEN DETECTED. THE PATIENT DATA FILE WAS NOT ACCESSIBLE. A DELAY IN THE SURGERY WAS REPORTED WITHOUT PRECISION ABOUT THE TIME.

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 BY THE RISK MANAGEMENT DEPARTMENT OF THE HOSPITAL THAT A PATIENT, WHO IS ALSO A NEURO-RADIOLOGIST, UNDERWENT A DA VINCI-ASSISTED MITRAL VALVE REPAIR PROCEDURE ON AN UNSPECIFIED DATE IN 2008. THE PATIENT IS LOOKING INTO THE POSSIBILITY THAT HE DEVELOPED POST-OPERATIVE BRAIN HEMORRHAGES RELATED TO METALLIC EMBOLI. THE PATIENT'S MEDICAL HISTORY IS REPORTEDLY COMPLICATED AND POST-OPERATIVE MRI FINDINGS HAVE NOT BEEN CONFIRMED. NO FURTHER CLINICAL INFORMATION WAS 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: ATTORNEYS HAVE ALLEGED THAT THEIR CLIENTS SUFFERED INJURIES ASSOCIATED WITH DA VINCI SURGICAL PROCEDURES. THESE CLAIMS DO NOT INVOLVE REPORTABLE DEATHS OR MALFUNCTIONS. THESE ALLEGATIONS WERE RECEIVED BY INTUITIVE SURGICAL, INC.(ISI) BETWEEN OCTOBER 1, 2015 - JANUARY 1, 2016. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM APRIL 2008 - MAY 2015.

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 11/03/2017, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5072789 WITH THE FOLLOWING EVENT DESCRIPTION: I HAD A TOTAL HYSTERECTOMY ON (B)(6) FOR ENDOMETRIAL CANCER. MY SURGEON USED THE DAVINCI ROBOTIC DEVICE TO PERFORM THE SURGERY. IN (B)(6), I WAS DIAGNOSED WITH RECURRENT CANCER AND A PEA-SIZED NODULE AT ONE OF THE DAVINCI PORT SITES WAS CONFIRMED POSITIVE FOR ENDOMETRIAL CANCER METASTASIS. ON 11/08/2017, ISI OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT DIRECTLY FROM THE PATIENT: THE PATIENT UNDERWENT A DA VINCI LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, WASHINGS, BILATERAL PELVIC AND PERIAORTIC LYMPH NODE DISSECTION SURGERY ON (B)(6) 2016. SHE WAS DIAGNOSED WITH ENDOMETRIAL ENDOMETRIOID STAGE 1A, GRADE 2, WITH 18 NEGATIVE LYMPH NODES. ON (B)(6) 2016, THE PATIENT HAD A VAGINAL VAULT LESION BIOPSY THAT WAS CONFIRMED POSITIVE FOR METASTATIC ENDOMETRIOID ADENOCARCINOMA. ON (B)(6) 2016, THE PATIENT HAD A BIOPSY OF A PEA-SIZED NODULE, LOCATED AT THE RIGHT LOWER QUADRANT ROBOTIC PORT SITE. THE PATIENT INDICATED THAT THE BIOPSY OF THE PEA-SIZED NODULE ALSO SHOWED INVOLVED BY METASTATIC ENDOMETRIOID ADENOCARCINOMA. ON 11/2

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE HAS BEEN DETECTED. AS A CONSEQUENCE THE DEVICE WAS STOPPED SEVERAL TIME DURING THE PROCEDURE. A SURGERY DELAY HAS BEEN REPORTED WITHOUT ANY PRECISION OF THE LIME LOST.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, THE HYDRAULIC STABILISATION SYSTEM WAS NON-FUNCTIONAL. IT HAS BEEN REPORTED THAT THE SURGERY HAS BEEN CANCELLED.

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 APPROXIMATELY 6 HOURS AFTER COMPLETION OF A DA VINCI-ASSISTED GASTRECTOMY PROCEDURE, THE PATIENT EXPERIENCED INTRA-OPERATIVE BLEEDING. THE PATIENT'S BLOOD PRESSURE DROPPED TO APPROXIMATELY 50 MMHG POST-OPERATIVELY. THE PATIENT'S HEMOGLOBIN LEVEL ALSO REPORTEDLY DROPPED TO 9.7 G/DL. BEFORE THE PROCEDURE BEGAN, THE PATIENT'S HEMOGLOBIN WAS 12.9 G/DL. DURING THE PROCEDURE, HIS HEMOGLOBIN LEVEL WAS 9.8 G/DL. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ACCORDING TO THE INITIAL REPORTER, THE PROGRESSION OF ANEMIA WAS NOT APPARENT AND THE PATIENT HAD LIGHTLY BLOODY DRAINAGE FROM AN UNSPECIFIED SOURCE. NO APPARENT ASCITES WAS FOUND VIA ULTRASOUND IN THE ABDOMINAL AREA. AFTER TRANSFUSIONS WERE ADMINISTERED, THE PATIENT'S BLOOD PRESSURE RECOVERED TO 80 MMHG. THE PATIENT'S RESPONSE WAS REPORTEDLY STILL POOR AND ABDOMINAL DISTENSION WAS NOTED. IN ADDITION, HIS DRAINAGE WAS NOTED TO BE BLOODY. THE PATIENT WAS THEN TAKEN BACK TO THE OR SINCE ABDOMINAL BLEEDING WAS IDENTIFIED. PRIOR TO THE START OF AN EMERGENCY OPERATION, THE PATIENT'S HEMOGLOBIN LEVEL WAS AT 6.7 G/DL. FRESH BLOOD AND BLOOD CLOTS IN THE INTRAPERITONEAL A

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE WAS DETECTED. A COMMUNICATION ERROR HAS BEEN IDENTIFIED. A SURGERY DELAY HAS BEEN REPORTED BETWEEN 30 MINUTES AND 1 HOUR.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, THE SUPPORT ARM ADAPTOR CLAMPING SCREW WAS DAMAGED. THE PROCEDURE HAS BEEN COMPLETED WITH A TRADITIONAL SURGERY TECHNIQUE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: (B)(6). RE: DA VINCI ROBOT IS A VERY DANGEROUS OPERATION DEVICE! DEAR SIR: I AM WRITING A LETTER TO YOU EXPLAINING JUST WHAT HAPPENED TO ME WHEN I WAS OPERATED ON VIA DA-VINCI ROBOT. FIRST OF ALL, MY UROLOGIST/SURGEON (MR. (B)(6)) TOLD ME AND MY FAMILY THAT I HAD DEVELOPED PROSTATE CANCER AND THAT I WOULD HAVE TO HAVE MY PROSTATE REMOVED BECAUSE ON THE GLEASON SCALE READING OF 6. DR. (B)(6) SAID THAT HE RECOMMENDED USING THE DA-VINCI ROBOT BECAUSE IT WOULD DO A BETTER JOB AND THAT IT WOULD ALLOW HIM TO SEE EVERYTHING ON A BIG SCREEN SO THAT HE WOULD BE ABLE NOT TO CUT ANY NERVES OR BLOOD VESSELS THAT WOULD AFFECT ME FROM HAVING SEX AND THAT IT WOULD PREVENT ME FROM HAVING INCONTINENCE. DR. (B)(6) CONVINCED ME AND MY FAMILY THAT THE DA-VINCI ROBOT WAS THE WAY TO GO AND THAT MY FAMILY COULD PICK ME UP AT THE HOSPITAL THE NEXT MORNING. WHEN MY FAMILY CAME TO GET ME, I WAS IN A BAD WAY. I COULD NOT STAND, EAT, MOVE AND I WAS IN SO MUCH PAIN. THE NURSES HAD PUT ON ME A DRAINAGE BAG AND ABOUT EVERY TWO HOURS THE BAG WOULD FILL UP WITH BRIGHT RED BLOOD JUST LIKE IF I HAD JUST CUT MYSELF. DRAINAGE WOULD NOT BE THE SAME COLOR AS PURE BLOOD. DR (B)(6) TOLD MY FAMILY THAT I WOULD NOT BE GOING

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE WAS DETECTED. A COMMUNICATION ERROR HAS BEEN IDENTIFIED. A SURGERY DELAY HAS BEEN REPORTED WITHOUT SPECIFIED TIME.

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 (B)(6) 2016, IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LEFT HEMICOLECTOMY PROCEDURE, AN UNSPECIFIED BIPOLAR INSTRUMENT AUTO-FIRED AND THE PATIENT SUSTAINED A BURN INJURY TO THE COLON. DETAILS REGARDING THE BURN INJURY WERE NOT INITIALLY PROVIDED. THE INITIAL REPORTER INDICATED THAT THE CORD OF THE BIPOLAR INSTRUMENT WAS CORRECTLY PLUGGED INTO A BIPOLAR PORT ON THE ELECTROSURGICAL UNIT (ESU). ON 01/12/2016, AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL FIELD SPECIALIST (TFS) PERFORMED A FIELD EVALUATION AT THE SITE. THE TFS DETERMINED THAT THE SURGICAL STAFF HAD ACCIDENTALLY PLUGGED THE BIPOLAR CONNECTORS INTO THE MONOPOLAR COAG PORT ON THEIR NON-ISI ESU. DURING THE FIELD EVALUATION, THE TFS OBSERVED A DA VINCI SURGICAL PROCEDURE AFTER VERIFYING THAT THE BIPOLAR CONNECTORS WERE PLUGGED INTO THE CORRECT PORT ON THE ESU. DURING THE SURGICAL PROCEDURE, THE DA VINCI SURGICAL SYSTEM WORKED APPROPRIATELY. AFTER THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED, THE SURGICAL STAFF SWITCHED THE BIPOLAR CONNECTORS ON THE ESU TO THE MONOPOLAR PORT. THE SURGICAL STAFF WAS THEN ABLE TO REPLICATE THE AUTO-FIRING ISSUE WITH A BIPOLAR INSTRUMENT. THE SURGICAL STAFF MADE NOTE OF THE ISSUE AND MA

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-ASSISTED SURGICAL PROCEDURE, THE SURGEON WAS USING A MONOPOLAR CURVED SCISSORS (MCS) AND A VESSEL IN CLOSE PROXIMITY TO THE INSTRUMENT QUICKLY BLANCHED AND THEN BURST. THE SURGEON PROVIDED INTUITIVE SURGICAL, INC. (ISI) WITH A VIDEO CLIP OF THE REPORTED EVENT. DURING THE VIDEO, A VESSEL TOWARDS THE BACK END OF AN MCS INSTRUMENT BLANCHED QUICKLY FROM PALE WHITE TO BRIGHT WHITE IN COLOR AND THEN BURST. THE VIDEO REVEALS THAT WHILE ENERGY WAS BEING APPLIED, THE BLADES OF THE MCS INSTRUMENT WERE RESTING AGAINST THE VESSEL THAT WAS EVENTUALLY DAMAGED. THE VIDEO CLIP ALSO REVEALED THAT THE MCS TIP COVER ACCESSORY INSTALLED ON THE MCS INSTRUMENT WAS TORN AT THE MOUTH OF THE ACCESSORY. HOWEVER, THERE IS NO INDICATION THAT THE ACCESSORY DAMAGE CAUSED OR CONTRIBUTED TO THE VESSEL INJURY. THE SURGEON CLAIMED THAT THIS EVENT MIGHT NOT HAVE OCCURRED IF HE HAD BEEN USING DIFFERENT ENERGY MODALITIES AND SETTINGS. ON (B)(6) 2015, ISI CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING REGARDING THE REPORTED EVENT: THE EVENT OCCURRED DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE THAT HE PERFORMED ON AN UNSPECIFIED DATE. THE VESSEL THAT BURST WAS THE RI

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, THERE WERE ENTRY ERRORS UP TO 1CM, CAUSING A VENOUS INJURY ON 1 TRAJECTORY. THE SURGEON HAD ABORTED THE SURGERY AFTER 7 IMPLANTED ELECTRODES DUE TO BLOODY CEREBRAL SPINAL FLUID ON THE 7TH ELECTRODE. ALL ELECTRODES WERE LOW, IN THE SAME DIRECTION. BECAUSE ALL ELECTRODES WERE INACCURATE IN THE SAME DIRECTION, THE SURGEON WAS AFRAID THERE WAS A SYSTEMATIC ISSUE WITH THE ROBOT.

ROSA Robotic Surgery — 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 SURGERY AN INACCURACY ISSUE HAS BEEN OBSERVED WHEN PLACING ONE ELECTRODE. NO REPORTED INJURY.

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 POST A DA VINCI ASSISTED GASTRIC BYPASS PROCEDURE PERFORMED ON (B)(6) 2015, THE PATIENT EXPERIENCED BLEEDING FROM AN ENTEROTOMY CLOSURE THE FOLLOWING DAY, REQUIRING THE PATIENT TO UNDERGO A 2ND SURGICAL PROCEDURE TO REPAIR THE CLOSURE. NO OTHER INFORMATION WAS 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: PROGRASP FORCEPS, WERE BEING USED AND SURGEON STATED THEY WEREN'T WORKING CORRECTLY. INSTRUMENT REMOVED FROM PT. UPON INSPECTION A WIRE WAS FRAYED ON DEVICE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: BEFORE THE SURGERY, IT HAS BEEN REPORTED THAT THE PC WAS NON-FUNCTIONAL. IT HAS BEEN REPORTED THAT THE SURGERY HAS BEEN CANCELLED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: BEFORE THE SURGERY, IT WAS IDENTIFIED THAT A SOFTWARE FAILURE HAS BEEN DETECTED. WHILE USING ROSANNA SOFTWARE, THE COMPUTER WOULD FREEZE, AND WOULD HAVE LINES ACROSS THE SCREEN. THE SURGERY WAS CANCELLED.

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 AFTER COMPLETION OF A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, THE PATIENT'S SMALL BOWEL HERNIATED THROUGH ONE OF THE 8MM ROBOTIC PORT SITES ON POST-OPERATIVE DAY 7. ON (B)(6) 2015 AND (B)(6) 2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INITIAL REPORTER WAS PRESENT DURING THE SURGICAL PROCEDURE. AFTER THE ROBOTIC PORTION OF THE CASE WAS COMPLETED, THE SURGEON CONVERTED TO TRADITIONAL LAPAROSCOPIC SURGERY TO FINISH AN ANASTOMOSIS. THERE WAS NO ALLEGATION FROM THE SURGEON OR SURGICAL STAFF THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ON (B)(6) 2015, THE PATIENT'S SMALL BOWEL WAS FOUND TO HAVE HERNIATED THROUGH ONE OF THE 8MM ROBOTIC PORT SITES. THE PATIENT UNDERWENT ANOTHER PROCEDURE TO REPAIR THE HERNIATION. THAT SAME DAY ON (B)(6) 2015, THE PATIENT REPORTEDLY CODED. THE INITIAL REPORTER DID NOT KNOW THE REASON AS TO WHY THE PATIENT CODED. THE INITIAL REPORTER STATED THAT THE SURGEON DOES NOT CLOSE ANY ROBOTIC PORT SITES THAT ARE LESS THAN 10MM. ON (B)(6) 2015, THE INITIAL REPOR

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 AFTER COMPLETION OF A DA VINCI-ASSISTED ESOPHAGECTOMY PROCEDURE PERFORMED ON (B)(6) 2015, THE PATIENT WAS READMITTED TO A HOSPITAL ON (B)(6) 2015 WHERE HE RECEIVED UNSPECIFIED TREATMENT FOR AN UNSPECIFIED LEAK. THE PATIENT REPORTEDLY PASSED AWAY IN (B)(6) 2016 FROM AN UNKNOWN CAUSE. HOWEVER, ACCORDING TO THE INITIAL REPORTER, THE SURGEONS WERE NOT ATTRIBUTING THE PATIENT'S DEATH TO THE DA VINCI-ASSISTED SURGICAL PROCEDURE. ON 05/06/2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. THERE WERE NO REPORTED INTRA-OPERATIVE COMPLICATIONS. THE DA VINCI-ASSISTED ESOPHAGECTOMY PROCEDURE WAS COMPLETED AND THE PATIENT INITIALLY DID VERY WELL. ON 05/10/2016 AND 05/11/2016, THE INITIAL REPORTER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT AFTER SPEAKING TO THE SURGEON: THE SURGEON WAS UNABLE TO PROVIDE DETAILS AS TO WHAT TYPE OF LEAK WAS IDENTIFIED. HE DID NOT KNOW IF THE LEAK WAS FROM AN ANASTOMOSIS OR A STAPLE LI

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: BEFORE THE SURGERY, IT HAS BEEN REPORTED THAT THE PC WAS NON-FUNCTIONAL. IT HAS BEEN REPORTED THAT THE SURGERY HAS BEEN CANCELLED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE WAS DETECTED. A COMMUNICATION ERROR HAS BEEN IDENTIFIED. A SURGERY DELAY HAS BEEN REPORTED BETWEEN 1 HOUR AND 90 MINUTES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ATTORNEYS HAVE ALLEGED THAT THEIR CLIENTS SUFFERED INJURIES ASSOCIATED WITH DA VINCI SURGICAL PROCEDURES. THESE CLAIMS DO NOT INVOLVE REPORTABLE DEATHS OR MALFUNCTIONS. THESE ALLEGATIONS WERE RECEIVED BY INTUITIVE SURGICAL, INC.(ISI) BETWEEN (B)(6) 2015. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM (B)(6) 2012 - (B)(6) 2015.

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 AFTER COMPLETION OF A DA VINCI-ASSISTED LEFT PULMONARY LOBECTOMY PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS ON POST-OPERATIVE DAY 1. THE PATIENT WAS FOUND TO HAVE A HEMATOMA ON HER SPLEEN AND REMAINED IN THE ICU FOR 2 DAYS. THE PATIENT'S HEMOGLOBIN REPORTEDLY DROPPED 5 GRAMS AND SHE WAS GIVEN 2 UNITS OF BLOOD. ACCORDING TO THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR), NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IN ADDITION, THERE WERE NO REPORTED INTRA-OPERATIVE COMPLICATIONS AND THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED. THE CSR INDICATED THAT THE SURGEON BELIEVED THAT THE WRISTS OF THE DA VINCI INSTRUMENTS OR TRADITIONAL LAPAROSCOPIC INSTRUMENTS USED THROUGH THE ASSISTANT PORT MADE CONTACT WITH THE SPLEEN WHICH CAUSED THE HEMATOMA. ON (B)(6) 2015, ISI CONTACTED THE SURGEON AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE SURGEON INDICATED THAT SHE INSERTED THE ASSISTANT TROCAR INTO THE 9TH INTERSPACE WHICH IS A FEW MILLIMETERS ABOVE THE DIAPHRAGM. THE SURGEON BELIEVES THE ASSISTANT SURGEON MAY HAVE BLUNTLY HIT THE SPLEEN THROUGH TH

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE HAS BEEN DETECTED. THE DEVICE STOPPED WITH AN ERROR MESSAGE "FATAL ERROR". IT HAS BEEN REPORTED THAT THE SURGERY HAS BEEN CANCELLED

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, AN INACCURACY ISSUE HAS BEEN OBSERVED FOR 3 PINS OUT OF 4. THE PROCEDURE HAS BEEN COMPLETED WITH A TRADITIONAL SURGERY TECHNIQUE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE PT IS A (B)(6) MALE ADMITTED TO THE MEDICAL CENTER ON (B)(6) 2015 WITH PRIMARY DIAGNOSIS OF PROSTATE CANCER. THE PT WAS UNDERGOING ROBOTIC ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY ON (B)(6) 2015. ABOUT FIVE MINUTES INTO THE ROBOTIC PORTION OF THE SURGERY THE CHIEF RESIDENT NOTICED A FOREIGN BLACK OBJECT INSIDE OF THE PT'S BODY. THE FOREIGN BODY WAS RETRIEVED AND EXAMINED. THE PIECE TURNED OUT TO BE A SMALL BLACK BAND THAT CAME OFF OF THE MONOPOLAR CURVED SCISSORS. THE BLACK BAND CAME OFF THE DISTAL PORTION OF THE SCISSORS SHAFT IN A SECTION JUST ABOVE THE INSULATED SLEEVE. THE BLACK BAND HAD A UNEVEN FRACTURE IN THE MATERIAL. THIS WAS THE FIRST TIME THE SCISSORS HAD BEEN USED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A ROBOTIC ASSISTED RIGHT INGUINAL HERNIA REPAIR, THE TIP OF THE HARMONIC SCALPEL BROKE OFF. THE TIP WAS RETRIEVED FROM THE PELVIS WITHOUT INCIDENT.

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 ROBOTIC HYSTERECTOMY, I AWAKENED IN A PUDDLE OF CLEAR LIQUID. THE LEAKAGE WAS SO SEVERE THAT I HAD TO WEAR SUPER ABSORBENT DIAPERS; THE DIAPERS NEEDED TO BE CHANGED AT LEAST 10 TIMES A DAY. I DEVELOPED RIGHT KIDNEY BLOCKAGE, HYDRONEPHROSIS, A URETEROVAGINAL FISTULA, AND URINARY INCONTINENCE. IT WAS DISCOVERED THAT MY URETER HAD BEEN SOWN IN THE VAGINAL CUFF. A SECOND SURGERY WAS REQUIRED TO PLACE A STENT IN MY KIDNEY. MORE SURGERY WILL BE NEEDED IN 6 WEEKS. WHETHER OR NOT MY KIDNEY WILL FUNCTION PROPERLY AGAIN IS STILL UNKNOWN.

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 01/06/2016, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5058365 WITH THE FOLLOWING EVENT DESCRIPTION: AFTER ROBOTIC HYSTERECTOMY, I AWAKENED IN A PUDDLE OF CLEAR LIQUID, THE LEAKAGE WAS SO SEVERE THAT I HAD TO WEAR SUPER ABSORBENT DIAPERS; THE DIAPERS NEEDED TO BE CHANGED AT LEAST 10 TIMES A DAY. I DEVELOPED RIGHT KIDNEY BLOCKAGE, HYDRONEPHROSIS, A URETEROVAGINAL FISTULA, AND URINARY INCONTINENCE. IT WAS DISCOVERED THAT MY URETER HAD BEEN SOWN IN THE VAGINAL CUFF. A SECOND SURGERY WAS REQUIRED TO PLACE A STENT IN MY KIDNEY. MORE SURGERY WILL BE NEEDED IN 6 WEEKS. WHETHER OR NOT MY KIDNEY WILL FUNCTION PROPERLY AGAIN IS STILL UNKNOWN. ON (B)(6) 2016, ISI CONTACTED THE PATIENT AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE PATIENT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2015 WITH NO REPORTED INTRA-OPERATIVE COMPLICATIONS. IN ADDITION, THERE WERE NO REPORTED ISSUES WITH THE DA VINCI SURGICAL SYSTEM. ON (B)(6) 2015, THE PATIENT UNDERWENT A SECOND SURGICAL PROCEDURE AT A DIFFERENT HOSPITAL TO HAVE A STENT PLACED. ACCORDING TO THE SURGEON WHO PLACED THE STENT, HER URETER HAD BEEN SEWN IN THE VAGINAL CUFF AND THERE WAS A HOLE B

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 AFTER COMPLETION OF A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL WITH HIGH TEMPERATURES AND WAS VERY SICK. ACCORDING TO THE INITIAL REPORTER, THE PATIENT'S BOWEL HAD BEEN REPORTEDLY NICKED AND THE PATIENT UNDERWENT ADDITIONAL SURGERY TO REPAIR THE BOWEL INJURY. ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: SHE WAS PRESENT DURING THE DA VINCI SURGICAL PROCEDURE. DURING THE SURGICAL PROCEDURE, THERE WERE NO REPORTS OF A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES. THE SURGICAL PROCEDURE WAS COMPLEX DUE TO EXTENSIVE ADHESIONS. THE PATIENT'S UTERUS WAS STUCK TO THE BOWEL AND SIDEWALL. THE SURGICAL PROCEDURE WAS COMPLETED WITH NO REPORTED INTRA-OPERATIVE COMPLICATIONS. ON AN UNSPECIFIED DATE POST-OPERATIVELY, THE PATIENT RETURNED TO THE HOSPITAL AND WAS VERY SICK. A GENERAL SURGEON PERFORMED EXPLORATORY SURGERY AND FOUND AN UNSPECIFIED BOWEL INJURY THAT WAS REPAIRED. THE DETAILS REGARDING THE TYPE OF BOWEL INJURY SUSTAINED AND THE REPAIR PERFORMED WERE NOT KNOWN. THE CSR INDICATED THAT SHE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE PROCEDURE WAS AN ELECTIVE TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY WITH DAVINCI ASSISTANCE, AND POSSIBLE LAPAROTOMY. FOLLOWING SPECIMEN REMOVAL TRANSVAGINALLY, THE DAVINCI ROBOTIC SYSTEM SUFFERED A SERIES OF FAULTS. TROUBLESHOOTING OF FAULTS WAS OVERRIDDEN SEVERAL TIMES RESULTING IN A SYSTEM OVERRIDE. INTUITIVE SURGICAL WAS CALLED BY THE CIRCULATING NURSE. INSTRUCTIONS WERE PROVIDED TO SHUT THE SYSTEM DOWN AND REBOOT WHICH WAS PERFORMED TWICE AND THE FAULT WAS UNRECOVERABLE. AT THIS POINT, THE PHYSICIAN COULD NOT PROCEED ANY FURTHER. THE DEVICE WAS UNDOCKED AND PHYSICIAN DECIDED TO CLOSE THE VAGINA TRANSVAGINALLY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, AN INACCURACY ISSUE HAS BEEN OBSERVED > 20 CM. IT HAS BEEN REPORTED THAT THE SURGERY HAS BEEN CANCELLED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, A TRAJECTORY ISSUE WAS OBSERVED. THE PROCEDURE HAS BEEN COMPLETED WITH A TRADITIONAL SURGERY TECHNIQUE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, ARM POSITION ISSUES WERE OBSERVED. THE PROCEDURE HAS BEEN COMPLETED WITH A TRADITIONAL SURGERY TECHNIQUE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ATTORNEYS HAVE ALLEGED THAT THEIR CLIENTS SUFFERED INJURIES ASSOCIATED WITH DA VINCI SURGICAL PROCEDURES. THESE CLAIMS DO NOT INVOLVE REPORTABLE DEATHS OR MALFUNCTIONS. THESE ALLEGATIONS WERE RECEIVED BY INTUITIVE SURGICAL, INC.(ISI) BETWEEN APRIL 1, 2015 - JULY 1, 2015. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM (B)(6) 2010 TO (B)(6) 2014.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ATTORNEYS HAVE ALLEGED THAT THEIR CLIENTS SUFFERED INJURIES ASSOCIATED WITH DA VINCI SURGICAL PROCEDURES. THESE CLAIMS DO NOT INVOLVED REPORTABLE DEATHS OR MALFUNCTIONS. THESE ALLEGATIONS WERE RECEIVED BY INTUITIVE SURGICAL, INC.(ISI) BETWEEN (B)(6) 2017 - (B)(6) 2018. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM (B)(6) 2014 - (B)(6) 2017.

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 AFTER COMPLETION OF A SINGLE-SITE DA VINCI CHOLECYSTECTOMY PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL ON POST-OPERATIVE DAY 2 WITH COMPLAINTS OF PAIN AND UNDERWENT REPAIR OF THE SMALL BOWEL. ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI), CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER WAS PRESENT DURING THE SURGICAL PROCEDURE THAT WAS COMPLETED WITH NO INTRA-OPERATIVE COMPLICATIONS. ACCORDING TO THE INITIAL REPORTER, THERE WERE NO REPORTS OF ANY MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. THE PATIENT WAS DISCHARGED HOME THE SAME DAY THAT THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED. ON POST-OPERATIVE DAY 2, THE PATIENT RETURNED TO THE HOSPITAL WITH COMPLAINTS OF ABDOMINAL PAIN. A SMALL BOWEL PERFORATION WAS FOUND AND THE PATIENT UNDERWENT A SMALL BOWEL RESECTION PROCEDURE. AFTER THE SMALL BOWEL DEFECT WAS REPAIRED, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND NO FURTHER POST-OPERATIVE COMPLICATIONS HAVE BEEN REPORTED AS OF THE DATE OF THIS REPORT. THE INITIAL REPORTER SPOKE TO THE SURGEON REGARDING THE REPORTED EVENT. ACCORDING TO THE INITIAL REPOR

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE HAS BEEN DETECTED. THE ROBOT EXPERIENCED A COLLISION BETWEEN THE INSTRUMENT ADAPTER AND ANCHOR BOLT AND THE SURGEON WAS FORCED TO SHUTDOWN THE DEVICE. UPON REBOOT, THE REGISTRATION AND PLAN WERE NO LONGER AVAILABLE IN THE PATIENT FOLDER. A SURGERY DELAY HAS BEEN REPORTED OF 2 HOURS.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, ROBOT EXPERIENCED A COLLISION BETWEEN THE INSTRUMENT ADAPTER AND ANCHOR BOLT AND WAS FORCED TO SHUTDOWN AND THE ROBOT ARM WAS NON-FUNCTIONAL. A SURGERY DELAY OF 2 HOURS HAS BEEN REPORTED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, "THE SURGEON HAD THE FEELING TO TOUCH SOMETHING DURING THE INCISION, HE THEREFORE DECIDED TO INCREASE THE DIAMETER OF HIS INCISION. THE PROCEDURE HAS BEEN COMPLETED WITH A TRADITIONAL SURGERY TECHNIQUE. ON THE 2D CONTROL THE PINS WERE NOT CORRECTLY POSITIONED. A REPOSITIONING OF ONE PIN HAS BEEN PERFORMED USING THE TRADITIONAL SURGICAL TECHNIQUE.

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 INITIALLY REPORTED THAT DURING A DA VINCI MITRAL VALVE REPAIR PROCEDURE, THE SURGEON ALLEGED THAT ARM 4 ON THE PATIENT SIDE CART (PSC) MOVED ON ITS OWN AND AS A RESULT, THE PATIENT'S HEART WAS PUNCTURED. THE SURGEON WAS ABLE TO REPAIR THE INJURY AND COMPLETE THE SURGICAL PROCEDURE. ON (B)(4) 2015, AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL FIELD SPECIALIST (TFS) PERFORMED A FIELD EVALUATION AT THE SITE AND WAS UNABLE TO REPLICATE THE REPORTED ISSUE WITH ARM 4 ON THE PSC. THE TFS TESTED THE DA VINCI SYSTEM AND VERIFIED THAT IT WAS READY FOR USE. THE TFS FOLLOWED UP WITH THE SITE AND ALSO VERIFIED THAT SUBSEQUENT DA VINCI SURGICAL PROCEDURES HAD BEEN PERFORMED WITH THE DA VINCI SYSTEM AND THERE WERE NO RECURRENCES OF THE ALLEGED ISSUE WITH ARM 4. ON (B)(4) 2015, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE DA VINCI SURGICAL PROCEDURE. THE CSR INDICATED THAT THE REPORTED EVENT OCCURRED TOWARDS THE BEGINNING OF THE SURGICAL PROCEDURE AFTER THE SURGEON HAD OPENED THE PERICARDIUM WITH A PERMANENT CAUTERY SPATULA INSTRUMENT INSTALLED ON ARM 4. AT THE TIME THE EVENT OCCURRED, THE CSR INDICATED THAT THE PATIENT WAS ON BYPASS AND THEREFORE NO B

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, THE INTERFACE BLOCK WAS DAMAGED AND THE FORCE SENSOR CABLE WAS NON-FUNCTIONAL. IT HAS BEEN REPORTED THAT THE SURGERY HAS BEEN CANCELLED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS MDR RELATES TO ONE OF THREE SIMILAR EVENTS THAT WERE REPORTED TOGETHER. SPECIFICALLY, IT WAS REPORTED THAT 3 DIFFERENT PATIENTS, EACH OF WHOM HAD A DA VINCI HYSTERECTOMY PROCEDURE PERFORMED BY THE SAME SURGEON ON DIFFERENT DAYS WITHIN A 6-WEEK PERIOD, RETURNED TO THE HOSPITAL AN UNSPECIFIED NUMBER OF DAYS POST-OPERATIVELY AND WERE FOUND TO HAVE SUSTAINED POST-OPERATIVE THERMAL BURN INJURIES TO A URETER. ON 08/05/2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE SURGEON STATED THAT ON (B)(6) 2015, HE PERFORMED A MULTI-PORT DA VINCI HYSTERECTOMY PROCEDURE. HE INDICATED THAT NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IN ADDITION, THERE WERE NO INTRA-OPERATIVE COMPLICATIONS REPORTED. AT THE END OF THE DA VINCI SURGICAL PROCEDURE, THE SURGEON INDICATED THAT HE HAD PERFORMED A CYSTOSCOPY AND BOTH URETERS WERE FOUND TO BE PULSING NORMALLY. ON AN UNSPECIFIED DATE POST-OPERATIVELY, THE PATIENT CAME BACK TO THE HOSPITAL AND A THERMAL BURN INJURY WAS FOUND ON ONE OF THE URETERS CLOSE TO WHERE THE URETER ENTERS THE BLADDER. A UROLOGIST REPAIRED THE URET

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, THE HSS WAS NON-FUNCTIONAL. THE PROCEDURE HAS BEEN COMPLETED WITH A TRADITIONAL SURGERY TECHNIQUE.