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.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED BY THE RISK MANAGEMENT DEPARTMENT OF THE HOSPITAL THAT A PATIENT, WHO IS ALSO A NEURO-RADIOLOGIST, UNDERWENT A DA VINCI-ASSISTED MITRAL VALVE REPAIR PROCEDURE ON AN UNSPECIFIED DATE IN 2008. THE PATIENT IS LOOKING INTO THE POSSIBILITY THAT HE DEVELOPED POST-OPERATIVE BRAIN HEMORRHAGES RELATED TO METALLIC EMBOLI. THE PATIENT'S MEDICAL HISTORY IS REPORTEDLY COMPLICATED AND POST-OPERATIVE MRI FINDINGS HAVE NOT BEEN CONFIRMED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ATTORNEYS HAVE ALLEGED THAT THEIR CLIENTS SUFFERED INJURIES ASSOCIATED WITH DA VINCI SURGICAL PROCEDURES. THESE CLAIMS DO NOT INVOLVE REPORTABLE DEATHS OR MALFUNCTIONS. THESE ALLEGATIONS WERE RECEIVED BY INTUITIVE SURGICAL, INC.(ISI) BETWEEN OCTOBER 1, 2015 - JANUARY 1, 2016. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM APRIL 2008 - MAY 2015.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 11/03/2017, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5072789 WITH THE FOLLOWING EVENT DESCRIPTION: I HAD A TOTAL HYSTERECTOMY ON (B)(6) FOR ENDOMETRIAL CANCER. MY SURGEON USED THE DAVINCI ROBOTIC DEVICE TO PERFORM THE SURGERY. IN (B)(6), I WAS DIAGNOSED WITH RECURRENT CANCER AND A PEA-SIZED NODULE AT ONE OF THE DAVINCI PORT SITES WAS CONFIRMED POSITIVE FOR ENDOMETRIAL CANCER METASTASIS. ON 11/08/2017, ISI OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT DIRECTLY FROM THE PATIENT: THE PATIENT UNDERWENT A DA VINCI LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, WASHINGS, BILATERAL PELVIC AND PERIAORTIC LYMPH NODE DISSECTION SURGERY ON (B)(6) 2016. SHE WAS DIAGNOSED WITH ENDOMETRIAL ENDOMETRIOID STAGE 1A, GRADE 2, WITH 18 NEGATIVE LYMPH NODES. ON (B)(6) 2016, THE PATIENT HAD A VAGINAL VAULT LESION BIOPSY THAT WAS CONFIRMED POSITIVE FOR METASTATIC ENDOMETRIOID ADENOCARCINOMA. ON (B)(6) 2016, THE PATIENT HAD A BIOPSY OF A PEA-SIZED NODULE, LOCATED AT THE RIGHT LOWER QUADRANT ROBOTIC PORT SITE. THE PATIENT INDICATED THAT THE BIOPSY OF THE PEA-SIZED NODULE ALSO SHOWED INVOLVED BY METASTATIC ENDOMETRIOID ADENOCARCINOMA. ON 11/2

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

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

da Vinci Surgical System — Death 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 INITIALLY REPORTED BY THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) THAT AFTER COMPLETION OF A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE PERFORMED ON (B)(6) 2016, THE PATIENT WAS IN A BAD GENERAL STATE AND WAS TRANSFERRED TO EMERGENCY SERVICE. A SURGEON REPORTEDLY FOUND A LITTLE WOUND ON THE SMALL INTESTINE AT UNSPECIFIED TIME AFTER THE DA VINCI PROCEDURE WAS COMPLETED. THE PATIENT WAS NOTED TO BE IN THE ICU. ON 02/29/2016 AND 03/03/2016, ISI RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE CSR AND THE ISI AREA SALES MANAGER (ASM). THE CSR WAS PRESENT DURING THE CASE AND THE INFORMATION SOURCE IS BASED ON THE CSR'S OBSERVATION AND DISCUSSIONS WITH THE PROCTOR: PRIOR TO UNDERGOING THE DA VINCI SURGICAL PROCEDURE, THE PATIENT HAD MULTIPLE, PREVIOUS ABDOMINAL SURGERIES AND COMPLICATIONS IN THE PAST INCLUDING A PARTIAL NEPHRECTOMY, CHOLECYSTECTOMY, BILE DUCT INFLAMMATION (CHOLEDOCH), AND A PERFORATION OF ANOTHER UNSPECIFIED STRUCTURE. THERE WERE NO REPORTS OF A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES DURING THE SURGICAL PROCEDURE. THE SURGICAL STAFF HAD DIFFICULTIES WITH PLACING THE TROCA

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

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 PARTIAL NEPHRECTOMY PROCEDURE, THE PATIENT EXPERIENCED UNSPECIFIED INTRA-OPERATIVE COMPLICATIONS AND THE CASE WAS CONVERTED TO OPEN SURGERY. POST-OPERATIVELY, THE PATIENT EXPERIENCED COMPLICATIONS AND THE PATIENT SUBSEQUENTLY PASSED AWAY ON AN UNKNOWN DATE. ON 03/18/2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER WAS NOT PRESENT DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THERE WERE NO REPORTS THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. TO HER KNOWLEDGE, THE PATIENT SUSTAINED AN UNSPECIFIED TYPE OF BOWEL INJURY. SHE DID NOT KNOW THE CAUSES OF THE PATIENT'S OPERATIVE COMPLICATIONS OR DEATH.

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

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

da Vinci Surgical System — 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 — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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 LAST WORDS, "THEY MESSED UP". IT'S HEARTBREAKING BECAUSE HE SUFFERED IN PAIN WHILE THE DOCTORS TRIED TO FIGURE IT OUT. OUR DOC