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.

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 AFTER COMPLETION OF A DA VINCI-ASSISTED TRANSORAL ROBOTIC (TORS) PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED A CAROTID BLEED AND BLED TO DEATH. ON JULY 26, 2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: ISI WAS INFORMED OF THE PATIENT DEATH BY THE SURGEON. THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2016 AND WAS UNRECORDED ON VIDEO. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THERE WERE ALSO NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. ON (B)(6) 2016, THE CAROTID BLEED WAS IDENTIFIED AND THE PATIENT PASSED AWAY THE SAME DAY. PRIOR TO PASSING AWAY, IT IS UNKNOWN IF THE PATIENT RECEIVED ANY MEDICAL INTERVENTION DUE TO THE CAROTID BLEED. IT IS UNCLEAR AT THIS TIME IF AN AUTOPSY HAS BEEN OR WILL BE PERFORMED. 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 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 — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON DECEMBER 12, 2017, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5073827, WITH THE FOLLOWING EVENT DESCRIPTION: ON (B)(6), MY MOTHER (B)(6), (DOB (B)(6)) WAS OPERATED ON VIA DA VINCI ROBOTIC PROCEDURE BY TWO PHYSICIAN AT ROPER HOSPITAL IN (B)(6) FOR RIGHT UPPER LOBECTOMY. SHE IMMEDIATELY COMPLAINED OF ABDOMINAL PAIN (NEAR 8TH INTERCOSTAL SPACE WHERE CAMERA FROM ROBOT WAS INSERTED). THAT AFTERNOON FOLLOWING PROCEDURE, AND EVERY DAY THEREAFTER (DOCUMENT IN NURSE'S NOTES) UNTIL IT WAS DISCOVERED A FEW WEEK [SIC] LATER, HER RIGHT COLON HAD BEEN PERFORATED FOR SOME TIME AND EMERGENCY SURGERY WAS PERFORMED, AND THEN ALMOST BLED OUT FROM ANASTOMOSIS. THE DELAYED DIAGNOSIS OF PERFORATED COLON RESULTED IN A HEALTH DECLINE THAT RESULTED IN HER DEATH ON (B)(6) 2016. SHE TESTED POSITIVE FOR C. FREUNDII, CITROBACTER FREUNDII IS A SPECIES FACULTATIVE ANEROBIC GRAM-NEGATIVE BACTERIA OF THE (ENTERFOBACTERIACEAE FAMILY) IN HER RIGHT LUNG, AND WHITE BLOOD CELL COUNT WAS 59,000 FROM BACTERIA'S AND STOOL LEAKING OUT INTO ABDOMINAL CAVITY. SHE ALSO TESTED POSITIVE FOR SEVERAL OTHER BACTERIA'S INCLUDING CANDIDA TROPICALIS (FUNGUS). THANK YOU FOR LOOKING INTO THIS MATTER TO HELP WITH

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 — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2016, MY MOTHER (B)(6), (DOB (B)(6)) WAS OPERATED ON VIA DA VINCI ROBOTIC PROCEDURE BY TWO PHYSICIANS AT ROPER HOSPITAL IN (B)(6) FOR RIGHT UPPER LOBECTOMY. SHE IMMEDIATELY COMPLAINED OF ABDOMINAL PAIN (NEAR 8TH INTERCOSTAL SPACE WHERE CAMERA FROM ROBOT WAS INSERTED). THAT AFTERNOON FOLLOWING PROCEDURE, AND EVERY DAY THEREAFTER (DOCUMENTED IN NURSE'S NOTES) UNTIL IT WAS DISCOVERED A FEW WEEK LATER, HER RIGHT COLON HAD BEEN PERFORATED FOR SOME TIME AND EMERGENCY SURGERY WAS PERFORMED, AND THEN ALMOST BLED OUT FROM ANASTOMOSIS. THE DELAYED DIAGNOSIS OF PERFORATED COLON RESULTED IN A HEALTH DECLINE THAT RESULTED IN HER DEATH ON (B)(6) 2016. SHE TESTED POSITIVE FOR C. FREUNDII, CITROBACTER FREUNDII IS A SPECIES OF FACULTATIVE ANEROBIC GRAM-NEGATIVE BACTERIA OF THE (ENTEROBACTERIACEAE FAMILY) IN HER RIGHT LUNG, AND WHITE BLOOD CELL COUNT WAS 59,000 FROM BACTERIA'S AND STOOL LEAKING OUT INTO ABDOMINAL CAVITY. SHE ALSO TESTED POSITIVE FOR SEVERAL OTHER BACTERIA'S INCLUDING CANDIDA TROPICALIS (FUNGUS). THANK YOU FOR LOOKING INTO THIS MATTER TO HELP WITH COMPLIANCE AND MAY BE PREVENTING THIS FROM HAPPENING TO OTHER PTS AND FAMILIES.

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

A child left the vicinity of his guardians and began running towards the machine. The machine veered to the left to avoid the child, but the child ran backwards directly into the front quarter of the machine, at which point the machine stopped and the child fell to the ground.

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

At approximately 10:23 a.m. on June 19, 2016, an employee was waiting for a sensor fault on A900 robotic cell to be cleared.The employee entered the robotic cell, seven robots present, and attempted to clear a sensor fault on the machine. The robot became activated and caught the employee from behind crushing her ribs and shoving the employee to a jig. The employee was killed.

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.

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 (B)(6) 2016, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5060196 WITH THE FOLLOWING EVENT DESCRIPTION: MY DAD WAS (B)(6), HE HAD TWO AREAS OF CANCER (COLON AND NEAR RECTUM) THAT HAD TO BE REMOVED BUT THEY WERE EARLY STAGES AND DID NOT REQUIRE CHEMO OR RADIATION. HE WAS HEALTHY AND STILL WORKED AS A SUPERVISOR FOR THE FEDERAL GOVERNMENT. HE WASN'T SICK AND HAD NO SYMPTOMS GOING INTO SURGERY. HE WASN'T TAKING ANY MEDS PRIOR TO SURGERY. ON (B)(6) 2016, HE HAD ROBOTIC SURGERY AT (B)(6) HOSPITAL IN (B)(6). SURGERY WAS SCHEDULED FOR 7 HRS, BUT TOOK 9 HRS. ON (B)(6) 2016, EMERGENCY SURGERY WAS PERFORMED TO REPAIR LEAKING ILEUM DUE TO NIPPED EQUIPMENT. BY THIS TIME, HIS ORGAN WERE HAVING PROBLEMS. ON (B)(6) 2016, ANOTHER EMERGENCY SURGERY. ON (B)(6) 2016, MY FATHER DIED. WHAT IS INTERESTING, I SENT A MASS EMAIL TO MY JOB REACHING OVER 100 PEOPLE TO EXPLAIN WHAT HAPPENED TO MY FATHER TO AVOID QUESTIONS. THERE WAS A CO-WORKER THAT LOST HER FATHER FROM ROBOTIC COLON SURGERY IN (B)(6) 2 YRS PRIOR. SHE EXPLAINED THE DOCTOR NIPPED AN AREA AND THEY HAD TO GO BACK INTO SURGERY TO FIX IT. HE LATER DIED; 7 DAYS LATER. PLEASE HELP US. THIS IS WRONG AND SO VERY SAD. MY FATHER'S L

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.