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.

da Vinci Surgical System — Death 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-ASSISTED ESOPHAGEAL DIVERTICULUM REPAIR AND MYOTOMY PROCEDURE, THE SURGEON ALLEGEDLY HIT THE PATIENT'S AORTA AND THE CASE WAS CONVERTED TO OPEN SURGERY. THE PATIENT REPORTEDLY PASSED AWAY SHORTLY AFTER IN THE ICU. ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE SURGICAL PROCEDURE. ACCORDING TO THE CSR, THE REPORTED EVENT OCCURRED ABOUT AN HOUR AFTER THE SURGEON HAD BEEN SITTING AT THE SURGEON SIDE CONSOLE (SSC). AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS PERFORMING DISSECTION AND WAS USING A MARYLAND BIPOLAR FORCEPS INSTRUMENT AND A FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THERE WAS NO ALLEGATION FROM THE SURGICAL STAFF THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A DAY AFTER THE EVENT OCCURRED, THE CSR SPOKE TO THE SURGEON. THE SURGEON DID NOT PROVIDE A POSSIBLE CAUSE TO THE INTRA-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT. HOWEVER, THE CSR INDICATED THAT SHE SPOKE TO A SURGICAL ASSISTANT WHO WAS PRESENT DURING THE SURGICAL PROCEDURE. ACCORDING TO THE CSR, THE SURGICAL ASSISTANT INFORMED HER THAT THE SURGEON NICK

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 — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 10/01/2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5056296 WITH THE FOLLOWING EVENT DESCRIPTION: THIS IS A LATE REPORT AS WE WERE UNAWARE WE COULD HAVE REPORTED EARLIER TO FDA. MY MOTHER, (B)(6), AT TIME OF DEATH, WAS UNDERGOING A MITRAL VALUE [SIC] REPAIR WITH THE SURGEON, DR. (B)(6) , USING THE DAVINCI ROBOT. THIS OCCURRED AT (B)(6) ON (B)(6) 2006. ACCORDING TO THE PHYSICIAN, THE ROBOT NICKED HER HEART WHICH RESULTED IN BLEEDING OUT AND EMERGENCY OPEN HEART SURGERY. SHE NEVER RECOVERED AND DEVELOPED SEPSIS INFECTION 4 DAYS LATER. WE WERE INFORMED LATER THAT OUR MOM WAS THE ONLY THE 3RD PATIENT FOR HEART VALVE SURGERY ON THIS ROBOT. WE ALSO ARE AWARE THAT ANOTHER WOMAN DIED SUBSEQUENTLY BY THE SAME ROBOT AND PHYSICIAN. THE DOCTOR LEFT TOWN AFTER THIS. (WE NEVER FILED A LAWSUIT DUE TO (B)(6) LAWS ON DAMAGES.) I AM WRITING THIS TO INFORM THE FDA AND TO NOTIFY YOU OF AN ADVERSE EVENT FOR YOUR STATS OF THIS DAVINCI ROBOT. MY HOPE IS THAT NO ONE WILL HAVE TO DIE FROM THIS ROBOT IN THE FUTURE IN THE CARDIAC REALM OF USE FOR DAVINCI. THANK YOU. (B)(6). THIS MDR ADDRESSES THE SECOND PATIENT DEATH NOTED IN THE EVENT DESCRIPTION. REFER TO THE MDR REPORT WITH PATIE

da Vinci Surgical System — Death 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 PASSED AWAY ON POST-OPERATIVE DAY 5. NO FURTHER CLINICAL INFORMATION IS AVAILABLE AT THIS 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 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 — Death 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-ASSISTED NEPHRECTOMY PROCEDURE, THE SURGEON ENCOUNTERED A LARGE AMOUNT OF BLEEDING AND THE SURGICAL PROCEDURE WAS CONVERTED TO OPEN SURGERY. ACCORDING TO THE INITIAL REPORTER, IT IS UNCLEAR IF THE SURGEON TORE THE RENAL ARTERY OR ACTUALLY GOT INTO THE AORTA. ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE CSR, HE WAS INFORMED BY MULTIPLE SOURCES AT THE SITE THAT THE PATIENT HAD PASSED AWAY AFTER BEING MOVED TO THE HOSPITAL FLOOR.

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

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI-ASSISTED PARACOLOSTOMY HERNIA REPAIR PROCEDURE ON (B)(6) 2015. THE PLAINTIFF'S ATTORNEY ALLEGES THAT THE PATIENT SUFFERED A PERFORATED SMALL BOWEL DURING THE SURGICAL PROCEDURE THAT WENT UNTREATED FOR SEVERAL DAYS BEFORE HIS DEATH. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR ANY OF THE PATIENT'S MEDICAL RECORDS. ACCORDING TO THE PLAINTIFF'S ATTORNEY, THE SURGEON ENCOUNTERED MULTIPLE MASSIVE ADHESIONS DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. THE PATIENT REPORTEDLY EXPERIENCED EXCRUCIATING ABDOMINAL PAIN THAT BEGAN THE EVENING THAT THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED. THE PATIENT WAS ADMINISTERED MULTIPLE UNSPECIFIED PAIN MEDICATIONS. POST-OPERATIVELY, THE PLAINTIFF'S ATTORNEY NOTED THAT THE PATIENT DEVELOPED CLINICAL AND LABORATORY SIGNS COMMONLY REFERRED TO AS RED FLAGS THAT WERE CONSISTENT WITH PERITONITIS, SEPSIS AND SEPTIC SHOCK, INCLUDING WITHOUT LIMITATION, ABDOMINAL PAIN, ABDOMINAL TENDERNESS, INCREASED WHITE BLOOD COUNT WITH BANDEMIA, PROGRESSIVE TACHYCARDIA, PROGRESSIVE HYPOXMIA, INCREASED RESPIRATORY RATE, RESPIRATORY

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

da Vinci Surgical System — Death 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 TORS PROCEDURE, THE PATIENT PASSED A FEW DAYS LATER. ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE CSR WAS NOT PRESENT DURING THE SURGICAL PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. ACCORDING TO THE CSR, NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS DURING THE DA VINCI SURGERY. THE CSR INDICATED THAT THE PATIENT PASSED AWAY ON (B)(6) 2015 AND AN AUTOPSY WAS TO BE PERFORMED.

da Vinci Surgical System — Death 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 MITRAL VALVE PROCEDURE, THE SURGEON EXPERIENCED DOUBLE VISION WITH THE 30 DEGREE ENDOSCOPE. THE INTUITIVE SURGICAL INC. (ISI)TECHNICAL SUPPORT ENGINEER (TSE) PROVIDED TROUBLESHOOTING STEPS INCLUDING ASSISTANCE IN RECALIBRATING A REPLACEMENT 30 DEGREE ENDOSCOPE; HOWEVER, THERE WAS NO CHANGE IN VISION. THE SURGEON DECIDED TO COMPLETE THE PROCEDURE USING TRADITIONAL OPEN SURGICAL TECHNIQUES. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY 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 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 — Death 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 PASSED AWAY ON POST-OPERATIVE DAY 2. ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INTUITIVE SURGICAL EMPLOYEE WHO INITIALLY REPORTED THE COMPLAINT AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: ON (B)(6) 2015, A PATIENT WITH A BIG, LATE T3/T4 GRADE TUMOR LOCATED IN THE LOWER RECTUM UNDERWENT A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE IN ORDER TO REMOVE THE TUMOR. DURING THE PROCEDURE, A SMALL ANASTOMOTIC LEAK WAS IDENTIFIED AFTER A LEAK TEST WAS PERFORMED. THE SURGEON WAS NOT SURE WHAT CAUSED THE ANASTOMOTIC LEAK. IT WAS INDICATED THAT A NON-ISI STAPLER INSTRUMENT HAD BEEN USED TO CREATE THE ANASTOMOSIS. THE PATIENT'S ABDOMEN WAS CLEANED WITH BETADINE AND A PROTECTIVE ILEOSTOMY WAS PLACED. ANTIBIOTICS WERE ALSO ADMINISTERED. ACCORDING TO THE INITIAL REPORTER, NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. THE INITIAL REPORTER ALSO INDICATED THAT THERE WERE NO ISSUES WITH ANESTHESIA. AFTER THE TUMOR WAS REMOVED AND THE SURGICAL PROCEDURE WAS COMPLETED, THE PATIENT WAS

At approximately 2:15 p.m. on July 7, 2015, Employee #1 was working near a robot. The robot was located within an enclosure. Employee #1 was working on a fixture and attempting to place a part into it. As he worked, the robot struck Employee #1, pinning and killing him.

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.

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 CRASH HAS BEEN DETECTED. 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, THE ROBOT STAND REFERENCE WAS NON-FUNCTIONAL. 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY AND MEDIASTINAL MASS LYMPHADENECTOMY PROCEDURE, A FELLOW SURGEON PUNCTURED THE PATIENT'S AORTA WHICH LED TO AN IMMEDIATE CONVERSION TO OPEN SURGERY. 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 INDICATED THAT THE FELLOW SURGEON WAS SEATED AT THE SURGEON SIDE CONSOLE (SSC) AND POSSIBLY PUNCTURED THE PATIENT'S AORTA WITH A MONOPOLAR CAUTERY INSTRUMENT OR SPATULA INSTRUMENT. ACCORDING TO THE INITIAL REPORTER, THERE WAS NO ALLEGATION FROM THE SITE THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE INITIAL REPORTER ALSO INDICATED THAT AFTER THE CASE WAS CONVERTED TO OPEN SURGERY, A COLECTOMY WAS PERFORMED AND A COLOSTOMY WAS PLACED. IN ADDITION, THE INITIAL REPORTER STATED THAT HE HEARD THAT POSSIBLY THE PATIENT LOST ONE OR BOTH LEGS AS A RESULT OF THE REPORTED EVENT.

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 CARDIOTHORACIC PROCEDURE, THE INITIAL REPORTER ALLEGED THAT THE SURGICAL STAFF, SPECIFICALLY A NURSE PRACTITIONER, FRACTURED THE PATIENT'S RIBS AND PUNCTURED A BREAST IMPLANT.