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. THIS ISSUE HAS BEEN IDENTIFIED DURING THE PATIENT DATA FILE CREATION. THERE WAS ONE HOUR DELAY ON THE SURGERY.

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 WAS REPORTED THAT DURING A SURGERY THERE WAS A LASER INACCURACY OBSERVED DURING THE REGISTRATION PROCESS. THE REGISTRATION WAS REPEATED TWICE AND THE SURGEON DECIDED TO PROCEED WITH SURGERY. A DELAY OF 30 MINUTES 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 APPROXIMATELY A FEW DAYS AFTER COMPLETION OF A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, A SMALL HOLE THAT WAS DESCRIBED AS BEING PIN POINT IN SIZE WAS FOUND IN THE BOWEL. AS A RESULT THE PATIENT CAME BACK WITH UNSPECIFIED SIGNS OF INFECTION AND UNDERWENT AN EXPLORATORY LAPAROTOMY PROCEDURE ON AN UNSPECIFIED DATE TO REPAIR THE HOLE IN THE BOWEL. ON 09/30/2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSR STATED THAT HE WAS NOT PRESENT DURING THE SURGICAL PROCEDURE AND THAT THE PROCEDURE WAS NOT RECORDED. APPROXIMATELY A FEW DAYS AFTER THE PROCEDURE THE CSR BELIEVES THE PATIENT CAME BACK TO THE HOSPITAL WITH SIGNS OF INFECTION. TO HIS KNOWLEDGE, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY PROCEDURE ON AN UNSPECIFIED DATE TO REPAIR THE HOLE. THE CSR MENTIONED THAT OTHER LAPAROSCOPIC INSTRUMENTS WERE USED DURING THE INITIAL CHOLECYSTECTOMY SURGICAL PROCEDURE. WHEN THE CSR FOLLOWED UP WITH THE SURGEON, THE SURGEON STATED ROBOTICALLY THE SURGERY WENT VERY WELL. THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS. ACCORDING TO THE CSR, TH

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) 2017, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5066629 WITH THE FOLLOWING EVENT DESCRIPTION: ON (B)(6) 2016 MY SON, (B)(6) HAD HIS GALL BLADDER REMOVED AT (B)(6) HOSPITAL BY ROBOTIC SURGERY. TWO DAYS LATER I TOOK HIM TO THE ER WHERE IT WAS DISCOVERED THAT HIS SMALL INTESTINES HAD BEEN PUNCTURED DURING SURGERY. ULTIMATELY, HE HAD TO HAVE SMALL BOWEL RESECTION, HE HAD PERITONITIS, ETC. LIST ALL CURRENT PRESCRIPTION MEDICATIONS AND MEDICAL DEVICES BEING USE: NONE, JUST FINISHED A 2-PACK, AS HE WAS JUST DIAGNOSED WITH PNEUMONIA. LIST ALL OVER-THE-COUNTER MEDICATIONS: NONE (ADVIL FOR PAIN) OCCASIONALLY, WHEN HE CANNOT STAND IT. ON (B)(6) 2017, ISI CONTACTED THE INITIAL REPORTER. HOWEVER, THE INITIAL REPORTER WAS UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE FOLLOWING INFORMATION IS UNKNOWN AT THIS TIME: HOSPITAL NAME WHERE THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED AND THE NAME OF THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 03/01/2017 FOR MW5066629: I SUBMITTED A MEDICAL DEVICE REPORT AFTER MY SON WAS INJURED FOLLOWING SURGERY WITH A DA VINCI ROBOTIC SYSTEM. (MW5066629) AFTER I SUBMITTED MY REPORT TO YOUR AGENCY, I RECEIVED A CALL FROM SOMEONE IN THE REGULATORY COMPLAINTS DEPARTMENT AT INTUITIVE SURGICAL (MAKERS OF THE DA VINCI ROBOTIC SYSTEM). HE SAID HE HAD RECEIVED A COPY OF MY SON'S INJURY REPORT FROM THE FDA AND HE WANTED TO KNOW THE NAME OF THE SURGEON AND THE HOSPITAL WHERE THE INJURY HAPPENED. HE HAD THE DATE OF THE SURGERY, KNEW FROM MY AREA CODE THAT I WAS FROM THE (B)(6) AREA AND SAID HE DID HAVE ONE REPORT OF AN INJURY BEING REPORTED IN (B)(6) ON OR AROUND THAT DATE. ((B)(6) 2016 WAS THE DATE OF THE INITIAL SURGERY, (B)(6) 2016 WAS THE DATE OF THE EMERGENCY SURGERY AFTER THE INJURY WAS DISCOVERED). I RESPONDED, "OH GOOD, SO THE SURGEON OR THE HOSPITAL DID REPORT THE INJURY PROCEEDING THE DA VINCI SURGERY TO YOUR COMPANY." THE MAN IN THE REGULATORY DEPARTMENT THEN SAID, "WELL NOT EXACTLY, THE SURGEON REPORTED THE INJURY TO OUR DA VINCI SALES PERSON, AND I FILED MY REPORT TO THE FDA BASED UPON WHAT OUR SALES PERSON REPORTED TO ME." (I FOUND IT

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 HYSTERECTOMY PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT'S URETER WAS CUT. THE PATIENT UNDERWENT 2 SUBSEQUENT SURGICAL PROCEDURES AND IS GOING TO UNDERGO A 3RD PROCEDURE TO REPAIR THE DAMAGE TO HER URETER. IT WAS ALSO REPORTED THAT THE PATIENT HAS A BAG. ON (B)(6) 2016 INTUITIVE SURGICAL, INC. (ISI) OBTAINED ADDITIONAL INFORMATION FROM THE PATIENT REGARDING THE REPORTED EVENT. ACCORDING TO THE PATIENT, SHE UNDERWENT THE PLANNED SURGICAL PROCEDURE ON (B)(6) 2016 AND WAS RELEASED FROM THE HOSPITAL THE FOLLOWING DAY. ON POST-OP DAY 3 SHE PRESENTED TO THE HOSPITAL'S EMERGENCY ROOM DEPARTMENT AND IT WAS DISCOVERED THAT HER URETER WAS CUT. ACCORDING TO THE PATIENT, THE DAMAGE TO HER URETER PREVENTED HER KIDNEY FROM DRAINING. IN ADDITION TO UNDERGOING TWO SUBSEQUENT LAPAROSCOPIC PROCEDURES TO RESOLVE THE DRAINAGE ISSUE SHE CURRENTLY HAS A TEMPORARY UROSTOMY BAG. SHE IS EXPECTED TO UNDERGO THE 3RD SURGICAL PROCEDURE TO REPAIR HER URETER IN APPROXIMATELY 1 MONTH. ACCORDING TO THE PATIENT, THERE WAS NO REPORT TO HER BY THE HOSPITAL THAT ANY MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM AND/OR INSTRUMENTS OCCURRED DURING THE SURGICAL PROCEDURE. 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 WAS REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE WAS DETECTED. A COMMUNICATION ERROR WAS IDENTIFIED. A SURGICAL DELAY BETWEEN 30 MINUTES AND 1 HOUR WAS 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 THERE WAS AN INACCURACY IN THE TRAJECTORY OF THE INSTRUMENT ADAPTOR DURING SURGERY. THE PROCEDURE WAS COMPLETED WITH A TRADITIONAL METHOD OF SURGERY.

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, 2016 - JULY 1, 2016. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM (B)(6) 2012 - (B)(6) 2014.

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 PATIENT WOKE UP, WHICH REQUIRED THE SURGEON TO PERFORM A NEW REGISTRATION. PRIOR TO THE PATIENT WAKING UP, 2 REGISTRATIONS WERE PERFORMED. AFTER THE PATIENT WOKE UP, A FURTHER 3 REGISTRATIONS WERE PERFORMED.

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 PHARYNGECTOMY PROCEDURE, THE PATIENT ALLEGEDLY SUFFOCATED BY ASPIRATION FROM LIGHT BLEEDING. ON 09/21/2017 AND 10/02/2017, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE SITE REGARDING THE REPORTED EVENT: THERE WAS NO REPORT OR ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE PATIENT ALSO DID NOT EXPERIENCE ANY INTRA-OPERATIVE COMPLICATIONS. POST-OPERATIVELY, ON AN UNSPECIFIED DATE, THE PATIENT DEVELOPED EDEMA IN THE THROAT AND EXPERIENCED DYSPHAGIA. IN ADDITION, THE PATIENT ALLEGEDLY EXPERIENCED SUFFOCATION AFTER ASPIRATING BLOOD. AS A RESULT, THE PATIENT WAS ADMINISTERED ARTIFICIAL RESPIRATION AND WAS TAKEN TO THE ICU. NO ADDITIONAL MEDICAL INTERVENTION WAS ADMINISTERED IN THE ICU. THE SITE ALSO INDICATED THAT NO MEDICAL INTERVENTION WAS ADMINISTERED SPECIFICALLY FOR THE POST-OPERATIVE LIGHT BLEEDING. ON 10/02/2017, ISI RECEIVED INFORMATION INDICATING THAT THE PATIENT WAS CURRENTLY IN GOOD CONDITION AND HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL.

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 AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, A PATIENT SUSTAINED AN INJURY TO THE LUNG AND AN INJURY TO THE LIVER. DETAILS REGARDING WHAT SPECIFIC TYPES OF INJURIES WERE SUSTAINED BY THE PATIENT WERE NOT PROVIDED. IN ADDITION, THE DATE AS TO WHEN THE DA VINCI SURGICAL PROCEDURE WAS PERFORMED IS UNKNOWN. ACCORDING TO THE SURGEON, THE INJURIES ALLEGEDLY OCCURRED DURING THE INSERTION OF A DYNAMIC ATRIAL RETRACTOR INSTRUMENT. THE SURGEON EXPLAINED THAT THERE IS ROUTINELY MORE RESISTANCE TO PASS INSTRUMENTS ON THE XI THAN ON THE SI SURGICAL SYSTEMS. THE SURGEON WAS REFERRING TO THE DIFFERENCE IN RESISTANCE WHEN INSERTING AN INSTRUMENT THROUGH A CANNULA SEAL ON THE DA VINCI XI SURGICAL SYSTEM COMPARED TO THE DA VINCI SI SURGICAL SYSTEM. THE SURGEON FURTHER STATED THAT THERE HAS BEEN NO RECURRENCE OF THE ISSUE AT THE SITE AND THE SURGICAL TEAM LEARNED FROM THE EXPERIENCE WITH A BETTER UNDERSTANDING OF THE RESISTANCE DIFFERENCES BETWEEN THE CANNULA SEALS OF THE TWO DA VINCI SURGICAL SYSTEMS. THE PATIENT REPORTEDLY REQUIRED SURGERY TO REPAIR THE LIVER INJURY THE DAY AFTER THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED.

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: DURING THE REGISTRATION STEP, IT HAS BEEN REPORTED THAT 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, A SOFTWARE FAILURE WAS DETECTED. A COMMUNICATION ERROR HAS BEEN IDENTIFIED. A SURGERY DELAY HAS BEEN REPORTED ABOUT 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 ROBOT ARM WAS NON-FUNCTIONAL. A COLLISION OCCURED LEADING TO SOFTWARE CRASH. A SURGERY DELAY OF 1 HOUR HAS BEEN 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 HAS BEEN REPORTED THAT AFTER COMPLETION OF THREE SEPARATE DA VINCI-ASSISTED SURGICAL PROCEDURES, EACH PATIENT DEVELOPED A SERIOUS POST-OPERATIVE INFECTION/ABSCESS. AS A RESULT OF THE POST-OPERATIVE COMPLICATIONS, TWO OF THE PATIENTS UNDERWENT A FOLLOW-UP, UNSPECIFIED SURGICAL PROCEDURE AND WERE THEN ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE TWO PATIENTS WERE REPORTEDLY RECEIVING ARTIFICIAL RESPIRATION. THE THIRD PATIENT WAS SCHEDULED TO UNDERGO AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2016, BUT IT IS UNKNOWN WHETHER THIS OCCURRED. ALL THREE PATIENTS HAD BLOOD RESULTS THAT WERE POSITIVE FOR DIFFERENT STRAINS OF ESCHERICHIA COLI (E.COLI) BACTERIA. ON JULY 22, 26, AND 29, 2016, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED POST-OPERATIVE INFECTIONS: REPORTEDLY, TWO OF THE AFFECTED PATIENTS UNDERWENT DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURES ON (B)(6) 2016. BOTH SURGICAL PROCEDURES WERE PERFORMED BY THE SAME SURGEON. THE THIRD PATIENT REPORTEDLY HAD A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE ON (B)(6) 2016, BY A DIFFERENT SURGEON. ALL THREE PATIENTS RECEIVED CEFUROXIME, AN ANTIBIOTIC, INTRAVENOUSLY. THE

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 HAS BEEN REPORTED THAT AFTER COMPLETION OF THREE SEPARATE DA VINCI-ASSISTED SURGICAL PROCEDURES, EACH PATIENT DEVELOPED A SERIOUS POST-OPERATIVE INFECTION/ABSCESS. AS A RESULT OF THE POST-OPERATIVE COMPLICATIONS, TWO OF THE PATIENTS UNDERWENT A FOLLOW-UP, UNSPECIFIED SURGICAL PROCEDURE AND WERE THEN ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE TWO PATIENTS WERE REPORTEDLY RECEIVING ARTIFICIAL RESPIRATION. THE THIRD PATIENT WAS SCHEDULED TO UNDERGO AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2016, BUT IT IS UNKNOWN WHETHER THIS OCCURRED. ALL THREE PATIENTS HAD BLOOD RESULTS THAT WERE POSITIVE FOR DIFFERENT STRAINS OF ESCHERICHIA COLI (E.COLI) BACTERIA. ON (B)(6) 2016, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED POST-OPERATIVE INFECTIONS: REPORTEDLY, TWO OF THE AFFECTED PATIENTS UNDERWENT DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURES ON (B)(6) 2016. BOTH SURGICAL PROCEDURES WERE PERFORMED BY THE SAME SURGEON. THE THIRD PATIENT REPORTEDLY HAD A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE ON (B)(6) 2016, BY A DIFFERENT SURGEON. ALL THREE PATIENTS RECEIVED CEFUROXIME, AN ANTIBIOTIC, INTRAVENOUSLY. THE E. COLI FROM T

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-ASSISTED GASTRECTOMY PROCEDURE, THE PATIENT EXPERIENCED BLEEDING FROM A BRANCH OF THE SUPERIOR PANCREATICODUODENAL ARTERY. THE SURGEON REPORTEDLY USED A FENESTRATED BIPOLAR FORCEPS INSTRUMENT AND COMPRESSION TO STOP THE BLEEDING. ACCORDING TO THE INITIAL REPORTER, IT TOOK THE SURGICAL STAFF APPROXIMATELY 6 HOURS TO CONTROL THE BLEEDING. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. APPROXIMATELY 23 MINUTES AFTER THE DA VINCI-ASSISTED GASTRECTOMY PROCEDURE WAS COMPLETED AND THE PATIENT'S ABDOMEN WAS CLOSED, THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP. A BLOODY DRAIN WAS ALSO IDENTIFIED. A TRANSFUSION WAS ADMINISTERED AND THE PATIENT'S BLOOD PRESSURE RECOVERED TO 70 MM HGS. THE PATIENT WAS REPORTEDLY DIAGNOSED WITH HEMOPERITONEUM AND INTRAPERITONEAL OBSERVATION WAS PERFORMED WITH A LAPAROSCOPE. FRESH BLOOD AND BLOOD CLOTS WERE FOUND. AFTER SUCTIONING WAS PERFORMED, THE SOURCE OF THE BLEEDING WAS FOUND TO BE THE PANCREATIC HEAD. THE SURGEON MADE THE DECISION TO PERFORM OPEN SURGERY IN ORDER TO CONTROL THE BLEEDING. THE SURGEON APPLIED SUTURES TO THE

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 HAS BEEN REPORTED THAT AFTER COMPLETION OF THREE SEPARATE DA VINCI-ASSISTED SURGICAL PROCEDURES, EACH PATIENT DEVELOPED A SERIOUS POST-OPERATIVE INFECTION/ABSCESS. AS A RESULT OF THE POST-OPERATIVE COMPLICATIONS, TWO OF THE PATIENTS UNDERWENT A FOLLOW-UP, UNSPECIFIED SURGICAL PROCEDURE AND WERE THEN ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE TWO PATIENTS WERE REPORTEDLY RECEIVING ARTIFICIAL RESPIRATION. THE THIRD PATIENT WAS SCHEDULED TO UNDERGO AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2016, BUT IT IS UNKNOWN WHETHER THIS OCCURRED. ALL THREE PATIENTS HAD BLOOD RESULTS THAT WERE POSITIVE FOR DIFFERENT STRAINS OF ESCHERICHIA COLI (E.COLI) BACTERIA. ON JULY 22, 26, AND 29, 2016, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED POST-OPERATIVE INFECTIONS: REPORTEDLY, TWO OF THE AFFECTED PATIENTS UNDERWENT DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURES ON (B)(6) 2016. BOTH SURGICAL PROCEDURES WERE PERFORMED BY THE SAME SURGEON. THE THIRD PATIENT REPORTEDLY HAD A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE ON (B)(6) 2016, BY A DIFFERENT SURGEON. ALL THREE PATIENTS RECEIVED CEFUROXIM, AN ANTIBIOTIC, INTRAVENOUSLY. THE E

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) BECAME AWARE OF THE UNPLUG THE ROBOT INTERNET BLOG TITLED, (B)(6) STORY. ACCORDING TO THE INTERNET BLOG, THE PATIENT ALLEGED THAT SHE EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE PERFORMED ON AN UNSPECIFIED DATE IN (B)(6) 2014. REFER TO THE FOLLOWING INTERNET LINK FOR ACCESS TO THE INTERNET BLOG: (B)(6). BASED ON THE INTERNET BLOG, THE FOLLOWING INFORMATION WAS PROVIDED: AFTER THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED, THE PATIENT WENT HOME THE SAME DAY. POST-OPERATIVELY, THE PATIENT EXPERIENCED HORRIFIC PAIN ON POST-OP DAY 5 AND FELT AS THOUGH SHE WAS SEVERELY CONSTIPATED. SHE REPORTEDLY HAD A SMALL FEVER AND VISITED HER PHYSICIAN. THE PATIENT INDICATED THAT THE PHYSICIAN THOUGHT SHE HAD A URINARY TRACT INFECTION (UTI) AND WAS PRESCRIBED AN UNSPECIFIED ANTIBIOTIC. THE FOLLOWING DAY, THE PATIENT REPORTEDLY COULDN'T MOVE AND WAS RUSHED TO AN ER WHERE A CAT-SCAN WAS PERFORMED. THE PATIENT WAS FOUND TO HAVE A VAGINAL CUFF HEMATOMA, INTERNAL BLEEDING, AND SEPSIS. THE PATIENT CLAIMED THAT HER BLOOD PRESSURE WAS 40/45 AND SHE WAS TEN MINUTES FROM DEATH. THE PATIENT ALLEGED

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 06/02/2016, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE UNPLUG THE ROBOT INTERNET BLOG COMMENT STATING: OMG OMG OMG, ONE OF THE LADIES THAT WE GO TO CHURCH WITH JUST CALLED ASKING FOR PRAYERS FOR HER NIECE, (B)(6) JUST HAD SURGERY, A HYSTERECTOMY WITH THE ROBOT AND THEY KNICKED [SIC] HER SMALL INTESTINE [SIC] DURING THE PROCEDURE AND IT WAS THE SAME DOCTOR THAT DID IT TO ME!!!!!!! SHE IS IN INTENSIVE CARE......PLEASE PRAY. THE INTERNET BLOG COMMENT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED OR CAUSED/CONTRIBUTED TO THE PATIENT'S OPERATIVE COMPLICATION. REFER TO THE FOLLOWING INTERNET LINK FOR ACCESS TO THE INTERNET BLOG: HTTP://UNPLUGTHEROBOT.BLOGSPOT.COM.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MAKO ROBOT BY STRYKER ORTHO FAILED. THE SENSORS STOPPED COMMUNICATING WITH THE COMPUTER. THIS HAPPENED AFTER BEGINNING A SURGERY FOR A KNEE REPLACEMENT. THE HOSPITAL HAD TO CALL IN ANOTHER COMPANY TO USE THEIR INSTRUMENTS AND IMPLANTS INSTEAD OF THE MAKO/STRYKER WHICH COULD NOT BE FIXED AFTER 15 MINUTES OF FAILED ATTEMPTS IN THE OPERATING ROOM.

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 06/02/2016, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE (B)(4) INTERNET BLOG TITLED, (B)(4). ACCORDING TO THE INTERNET BLOG, THE PATIENT ALLEGED THAT SHE EXPERIENCED MULTIPLE POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE PERFORMED ON AN UNSPECIFIED DATE IN (B)(6) 2014. THE INTERNET BLOG DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED OR CAUSED/CONTRIBUTED TO THE OPERATIVE COMPLICATIONS. REFER TO THE FOLLOWING INTERNET LINK FOR ACCESS TO THE INTERNET BLOG: (B)(4) BASED ON THE INTERNET BLOG, THE FOLLOWING INFORMATION WAS PROVIDED: THE PATIENT INDICATED THAT THE SURGEON INFORMED HER THAT SHE HAD NICKED THE OUTER LAYER OF THE BOWEL. HOWEVER, THE SURGEON REPORTEDLY DENIED THAT SHE HAD PUNCTURED THE PATIENT'S BOWEL. THE PATIENT CLAIMED THAT SHE WAS INFORMED THAT THE SURGICAL PROCEDURE WOULD LAST 2-3 HOURS. HOWEVER, ACCORDING TO THE PATIENT, THE DA VINCI-ASSISTED SURGICAL PROCEDURE TOOK ALMOST 6 HOURS. DURING THE MIDDLE OF THE NIGHT, THE PATIENT INDICATED THAT HER BLOOD PRESSURE DROPPED DANGEROUSLY AND SHE WAS GIVEN LOTS OF MEDICATION TO RAISE HER BLOOD PRESSURE. DUE TO HER BLOO

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 06/01/2016, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE UNPLUG THE ROBOT INTERNET BLOG TITLED, TINA'S STORY. ACCORDING TO THE INTERNET BLOG, THE PATIENT INDICATED THAT SHE UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE AND CLAIMED THAT THE SURGEON DAMAGED NERVES IN HER BLADDER AND POSSIBLY INTESTINES. AS A RESULT, THE PATIENT ALSO CLAIMED THAT SHE HAS EXPERIENCED NUMEROUS POST-OPERATIVE COMPLICATIONS. THE INTERNET BLOG DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED OR CAUSED/CONTRIBUTED TO THE OPERATIVE COMPLICATIONS. REFER TO THE FOLLOWING INTERNET LINK FOR ACCESS TO THE INTERNET BLOG: (B)(4). BASED ON THE INTERNET BLOG, THE FOLLOWING INFORMATION WAS PROVIDED: AFTER CONSULTING WITH HER SURGEON, THE PATIENT MADE THE DECISION TO UNDERGO A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE ON AN UNSPECIFIED DATE IN (B)(6) 2014. ACCORDING TO THE PATIENT, SHE EXPERIENCED A LOT OF PAIN WHILE IN THE RECOVERY ROOM AND WAS TREATED WITH AN UNSPECIFIED PAIN PILL. THE PATIENT ALSO MENTIONED THAT SHE STARTED BLEEDING AND HAVING MORE PAIN. THE PATIENT WAS REPORTEDLY GIVEN A PAD AND INFORMED THAT SHE WOULD BE FINE. THE PATIENT WAS

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 WITH PARA-AORTIC LYMPH NODE DISSECTION PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS. ACCORDING TO THE INITIAL REPORTER, AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR), THE SURGEON INFORMED HER THAT THE DA VINCI - ASSISTED SURGICAL PROCEDURE WAS SMOOTH AND STRAIGHTFORWARD. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. IN ADDITION, THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ON POST-OPERATIVE DAY 1, THE PATIENT'S STOMACH WAS NOTED TO BE DISTENDED AND THE PATIENT DID NOT SEEM TO BE WELL. ON POST-OPERATIVE DAY 2, A CT-SCAN WAS PERFORMED ON THE PATIENT AND WAS FOUND TO BE NEGATIVE. ON POST-OPERATIVE DAY 3, ANOTHER CT-SCAN WAS PERFORMED AND A PERFORATION OF THE DUODENUM WAS IDENTIFIED. ON POST-OPERATIVE DAY 6, THE PATIENT UNDERWENT OPEN SURGERY TO REPAIR A 5 MM PERFORATION OF THE DUODENUM. THE CSR INDICATED THAT THE SURGEON INFORMED HER THAT THE BOWEL PERFORATION WAS SURROUNDED BY WHITISH TISSUE MEASURING 1 CM X 1 CM. ACCORDING TO THE CSR, THE SITE BELIEVES THE WHITISH TISSUE AND PERFORAT

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 ARM WAS NON-FUNCTIONAL AND A COLLISION OF OPTICAL DISTANCE SENSOR WITH SUPPORT ARM WAS OBSERVED. 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, A SOFTWARE CRASH HAS BEEN DETECTED. 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, A SOFTWARE FAILURE HAS BEEN DETECTED. AS A CONSEQUENCE THE DEVICE STOPPED AND RESTARTED. 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 WAS REPORTED TO US THAT A PATIENT SUFFERED AN INTRA-OPERATIVE HEMATOMA DURING AN SEEG PROCEDURE. WITHIN A COUPLE HOURS AFTER SURGERY, THE PATIENT HAD ANOTHER EPIDURAL HEMATOMA (NOT AN INTRACEREBRAL HEMORRHAGE) IN THE SAME LOCATION AND HAD TO BE BROUGHT BACK TO THE OR. TWO DAYS AFTER THE SURGERY, A MEDTECH REPRESENTATIVE MET WITH THE SURGEON TO DISCUSS OUTCOMES. THE SURGEON STATED THAT THE PATIENT WAS DOING WELL. THE SURGEON CHOSE TO KEEP THE ELECTRODES IN PLACE, ALL ELECTRODES HAD GOOD SIGNAL: THEY WERE CLOSE ENOUGH TO THEIR TARGETS THAT THEY CAN RECORD THE BRAIN ACTIVITY OF INTEREST.

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 THE DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE THE SURGICAL STAFF EXPERIENCED A LOSS OF 3D VISION. AS A RESULT, IT WAS ALLEGED THAT THE SURGICAL PROCEDURE WAS PROLONGED AND THE PATIENT EXPERIENCED AN ABNORMAL BLOOD LOSS. NO DETAILS WERE PROVIDED REGARDING THE SEVERITY OR QUANTITY OF THE BLOOD LOSS. IT IS UNKNOWN HOW LONG THE PROCEDURE WAS PROLONGED. ALSO, IT IS UNKNOWN IF MEDICAL INTERVENTION OR ADDITIONAL ANESTHESIA WAS ADMINISTERED DUE TO THE ABNORMAL BLOOD LOSS OR PROLONGED PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENT. ON (B)(6) 2016, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE WAS ABLE TO REPLICATE THE REPORTED VISION ISSUES WITH THE DA VINCI SYSTEM. THE FSE RESOLVED THE REPORTED VISION ISSUES BY REPLACING THE HRSV AND BLUE FIBER CABLE. THE FSE THEN TESTED THE DA VINCI SURGICAL SYSTEM AND VERIFIED THAT IT WAS READY FOR USE. ON (B)(6) 2016, ISI CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE ALLEGED VISION ISSUE OCCURRED JUST AT THE BEGINNING OF THE PROCEDURE. AT THE TIME THE EVENT OCCURRED, AN IS

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 OCCURRED. THE PATIENT DATA FILE WAS NOT ACCESSIBLE. THE PROCEDURE WAS 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: ON 04/26/2016, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE (B)(6) ARTICLE TITLED, DO YOU NEED COMPLEX SURGERY? SOME DOCTORS MAY NOT HAVE MUCH PRACTICE (2016). ACCORDING TO THE ARTICLE, A (B)(6) MALE PATIENT CHOSE TO UNDERGO ELECTIVE ABDOMINAL SURGERY IN HIS HOME TOWN OF (B)(6), AFTER ROBOTIC PROSTATE SURGERY AT A LARGER HOSPITAL IN (B)(6) NEARLY KILLED HIM AND LEFT HIM WITH A COLOSTOMY. THE PATIENT REPORTEDLY WANTED TO BE BACK IN HIS TOWN AND HAD CONFIDENCE IN HIS SURGEON. THE PATIENT UNDERWENT A SEVEN-HOUR OPERATION THAT WENT WELL AT A SPECIFIED HOSPITAL. THE ARTICLE INDICATED THAT THE PATIENT RECENTLY SAID HE IS ALMOST BACK TO NORMAL.

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 THE DA VINCI-ASSISTED ESOPHAGECTOMY PROCEDURE THE PATIENT EXPERIENCED AN INTRA-OPERATIVE COMPLICATION WHICH REQUIRED CONVERSION TO OPEN SURGERY. ACCORDING TO THE INITIAL REPORTER, THE DA VINCI-ASSISTED SURGICAL PROCEDURE STARTED AT 12:15 PM. THE PROCEDURE PROGRESSED UNEVENTFULLY UNTIL THE ESOPHAGEAL DISSECTION WAS NEARLY COMPLETED. AT THAT POINT, MAJOR BLEEDING WAS OBSERVED AT 1:46 PM BY THE CONSOLE SURGEON. THE SURGEON WAS ABLE TO CONTROL THE BLEEDING QUICKLY BY APPLYING PRESSURE WITH AN UNSPECIFIED ROBOTIC INSTRUMENT. THE INITIAL REPORTER INDICATED THAT THE ESTIMATED BLOOD LOSS AT THAT STAGE OF THE SURGICAL PROCEDURE WAS 30 ML. THE SURGEON WAS UNABLE TO APPLY A CLIP OR SUTURES DUE TO POSITIONING; THEREFORE, THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGERY AT 2:20 PM WITH A VASCULAR CONSULTANT PRESENT AND IN CHARGE. THE INITIAL REPORTER INDICATED THAT THE SITE BELIEVES AN UNSPECIFIED THORACIC BRANCH OF THE AORTA HAD A HOLE. WHILE ATTEMPTING TO REPAIR THE HOLE VIA OPEN SURGERY, THE VESSEL DEFECT APPARENTLY WIDENED TO THE POINT WHERE THE AORTA BECAME INVOLVED. AFTER A THORACIC SURGEON WAS ABLE TO SUCCESSFULLY REPAIR THE VESSEL DEFECT WIT

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 JANUARY 2, 2016 - MARCH 31, 2016. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM (B)(6) 2010 - (B)(6) 2015.

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 STOPPED AND RESTARTED. 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, A SOFTWARE FAILURE HAS BEEN DETECTED. THREE CONSECUTIVE ERRORS OCCURRED ON ONE TRAJECTORY WHILE IN AXIAL SLOW MODE. 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 HEAD HOLDER ADAPTOR 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 HAS BEEN DETECTED. IT WAS IMPOSSIBLE TO PERFORM THE REGISTRATION STEP. 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, A SOFTWARE FAILURE WAS DETECTED. A COMMUNICATION ERROR HAS BEEN IDENTIFIED. 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, THE ETHERNET PORT WAS NON-FUNCTIONAL. 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 HEAD HOLDER ADAPTOR WAS NON-FUNCTIONAL. THE TIGHTENING KNOB ON SUPPORT ARM WAS BROKEN. AS A CONSEQUENCE, 1 ELECTRODE HAS NOT BEEN IMPLANTED. NO ADDITIONAL PATIENT IMPACT HAS BEEN 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 AFTER COMPLETION OF A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF NOTICED THAT THE PORT SITE INCISIONS WERE DISCOLORED. THE INCISION PORT SITES WERE DESCRIBED AS BEING WHITE WITH A DISCOLORED SURROUNDING AREA IN RED. THE PORT SITE INCISIONS REPORTEDLY DID NOT CLOSE POST-OPERATIVELY AFTER A FEW DAYS AND THE PORT SITES ALLEGEDLY BECAME INFECTED. ACCORDING TO THE INITIAL REPORTER, DEBRIDEMENT WAS PERFORMED TO HELP CLOSE EACH PORT SITE INCISION. THE INITIAL REPORTER ALSO INDICATED THAT THE POST-OPERATIVE PORT SITE INFECTIONS HAD OCCURRED IN 3 PREVIOUS DA VINCI-ASSISTED PROSTATECTOMY PROCEDURES PERFORMED BY THE SAME SURGEON. IN THIS PARTICULAR CASE, THE INITIAL REPORTER INDICATED THAT A LAPAROSCOPIC (NON-ROBOTIC) ASSIST PORT SITE HAD ALSO BECOME INFECTED POST-OPERATIVELY. THE INITIAL REPORTER INDICATED THAT 33 OTHER DA VINCI-ASSISTED SURGICAL PROCEDURES PERFORMED BY A DIFFERENT SURGEON DID NOT RESULT WITH POST-OPERATIVE PORT SITE INFECTIONS. BOTH SURGEONS WERE REPORTEDLY USING THE SAME GENERATOR SETTINGS. THE SITE PROVIDED 2 SEPARATE AND DIFFERENT PHOTOGRAPHIC IMAGES OF THE RELATED PORT SITE INFECTIONS. THE 2 IMAGES REVEAL VARIOUS PORT SITES WITH E

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 PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF NOTICED THAT THE PORT SITE INCISIONS WERE DISCOLORED. THE INCISION PORT SITES WERE DESCRIBED AS BEING WHITE WITH A DISCOLORED SURROUNDING AREA IN RED. THE PORT SITE INCISIONS REPORTEDLY DID NOT CLOSE POST-OPERATIVELY AFTER A FEW DAYS AND THE PORT SITES ALLEGEDLY BECAME INFECTED. ACCORDING TO THE INITIAL REPORTER, DEBRIDEMENT WAS PERFORMED TO HELP CLOSE EACH PORT SITE INCISION. THE INITIAL REPORTER ALSO INDICATED THAT THE POST-OPERATIVE PORT SITE INFECTIONS HAD OCCURRED IN (B)(6) ADDITIONAL DA VINCI-ASSISTED PROSTATECTOMY PROCEDURES PERFORMED BY THE SAME SURGEON. THE INITIAL REPORTER INDICATED THAT (B)(6) OTHER DA VINCI-ASSISTED SURGICAL PROCEDURES PERFORMED BY A DIFFERENT SURGEON DID NOT RESULT WITH POST-OPERATIVE PORT SITE INFECTIONS. BOTH SURGEONS WERE REPORTEDLY USING THE SAME GENERATOR SETTINGS. THE SITE PROVIDED 2 SEPARATE AND DIFFERENT PHOTOGRAPHIC IMAGES OF THE RELATED PORT SITE INFECTIONS. THE 2 IMAGES REVEAL VARIOUS PORT SITES WITH EVIDENCE OF POSSIBLE POST-OPERATIVE INFECTIONS AND AT VARIOUS STAGES OF HEALING. THE SITE INITIALLY DETERMINED THAT THE POST-OPERATIVE PORT

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 PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF NOTICED THAT THE PORT SITE INCISIONS WERE DISCOLORED. THE INCISION PORT SITES WERE DESCRIBED AS BEING WHITE WITH A DISCOLORED SURROUNDING AREA IN RED. THE PORT SITE INCISIONS REPORTEDLY DID NOT CLOSE POST-OPERATIVELY AFTER A FEW DAYS AND THE PORT SITES ALLEGEDLY BECAME INFECTED. ACCORDING TO THE INITIAL REPORTER, DEBRIDEMENT WAS PERFORMED TO HELP CLOSE EACH PORT SITE INCISION. THE INITIAL REPORTER ALSO INDICATED THAT THE POST-OPERATIVE PORT SITE INFECTIONS HAD OCCURRED IN 3 ADDITIONAL DA VINCI-ASSISTED PROSTATECTOMY PROCEDURES PERFORMED BY THE SAME SURGEON. THE INITIAL REPORTER INDICATED THAT 33 OTHER DA VINCI-ASSISTED SURGICAL PROCEDURES PERFORMED BY A DIFFERENT SURGEON DID NOT RESULT WITH POST-OPERATIVE PORT SITE INFECTIONS. BOTH SURGEONS WERE REPORTEDLY USING THE SAME GENERATOR SETTINGS. THE SITE PROVIDED 2 SEPARATE AND DIFFERENT PHOTOGRAPHIC IMAGES OF THE RELATED PORT SITE INFECTIONS. THE 2 IMAGES REVEAL VARIOUS PORT SITES WITH EVIDENCE OF POSSIBLE POST-OPERATIVE INFECTIONS AND AT VARIOUS STAGES OF HEALING. THE SITE INITIALLY DETERMINED THAT THE POST-OPERATIVE PORT SITE INFE

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 "SURGEON IMPLANTED A (B)(6) PATIENT WITH TWO VISUALASE LASER FIBERS FOR A HYPOTHALAMIC HAMARTOMA. DUE TO THE PATIENT'S AGE, THE PATIENT WAS STABILIZED IN A SEGUIDA HEADFRAME AND THE ROSA WAS ATTACHED TO THE BED. REGISTRATION WAS PERFORMED WITH 6 BONE FIDUCIALS AND AN RMS OF APPROX. 1.1 MM WAS ACQUIRED. DURING THE SCRUB, IT APPEARED THAT THE PATIENT'S SCALP MAY HAVE SHIFTED A BIT. THE SURGEON WAS FINE WITH STABILITY OF THE PATIENT'S HEAD. AFTER SCRUB, EACH LASER FIBER (ONE LEFT, ONE RIGHT) WAS IMPLANTED AND THE PATIENT WAS TAKEN TO MR. UPON FUSING THE POST-OP MR, IT WAS NOTICED THAT EACH IMPLANT WAS APPROXIMATELY 3.5 MM POSTERIOR TO THE PLAN.

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 PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF NOTICED THAT THE PORT SITE INCISIONS WERE DISCOLORED. THE INCISION PORT SITES WERE DESCRIBED AS BEING WHITE WITH A DISCOLORED SURROUNDING AREA IN RED. THE PORT SITE INCISIONS REPORTEDLY DID NOT CLOSE POST-OPERATIVELY AFTER A FEW DAYS AND THE PORT SITES ALLEGEDLY BECAME INFECTED. ACCORDING TO THE INITIAL REPORTER, DEBRIDEMENT WAS PERFORMED TO HELP CLOSE EACH PORT SITE INCISION. THE INITIAL REPORTER ALSO INDICATED THAT THE POST-OPERATIVE PORT SITE INFECTIONS HAD OCCURRED IN 3 ADDITIONAL DA VINCI-ASSISTED PROSTATECTOMY PROCEDURES PERFORMED BY THE SAME SURGEON. THE INITIAL REPORTER INDICATED THAT 33 OTHER DA VINCI-ASSISTED SURGICAL PROCEDURES PERFORMED BY A DIFFERENT SURGEON DID NOT RESULT WITH POST-OPERATIVE PORT SITE INFECTIONS. BOTH SURGEONS WERE REPORTEDLY USING THE SAME GENERATOR SETTINGS. THE SITE PROVIDED 2 SEPARATE AND DIFFERENT PHOTOGRAPHIC IMAGES OF THE RELATED PORT SITE INFECTIONS. THE 2 IMAGES REVEAL VARIOUS PORT SITES WITH EVIDENCE OF POSSIBLE POST-OPERATIVE INFECTIONS AND AT VARIOUS STAGES OF HEALING. THE SITE INITIALLY DETERMINED THAT THE POST-OPERATIVE PORT SITE INFE

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 SURGERY DELAY HAS BEEN REPORTED BETWEEN 30 MINUTES AND 1 HOUR.

da Vinci Surgical System — Injury 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 REPORTEDLY UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE ON (B)(6) 2016. THE PLAINTIFFS¿ ATTORNEY ALLEGES THAT DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT¿S LEFT URETER WAS SEVERED. AS A RESULT, THE PLAINTIFF¿S ATTORNEY CLAIMS THAT THE PATIENT HAS SUFFERED CHRONIC URINARY TRACT INFECTIONS, BLADDER LEAKAGE, PAIN, AND OTHER UNSPECIFIED PROBLEMS. IN ADDITION, THE PATIENT HAS REPORTEDLY BEEN A FREQUENT PATIENT AT HOSPITALS SINCE THE SURGERY TO ATTEMPT TO CORRECT HER PROBLEMS. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR ANY OF THE PATIENT¿S MEDICAL RECORDS.

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 AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INITIAL REPORTER ALLEGED THAT A WOMAN SUSTAINED A PUNCTURED IMPLANT DURING ROBOTIC SURGERY.