da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY SURGICAL PROCEDURE, THE SURGEON WAS USING THE HARMONIC ACE BLADE TO DISSOCIATE THE TISSUE WHEN THE CURVED BLADE SEPARATED FROM THE INSTRUMENT WHILE INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED, AND THE INSTRUMENT WAS REPLACED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM, ADVERSE OUTCOME, OR INJURY. DUE TO THE ALLEGED ISSUE, THE PROCEDURE WAS DELAYED BY 15 MINUTES. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTED PRODUCT WAS INSPECTED PRIOR TO USE. ALL FRAGMENT(S) WERE RETRIEVED. THE ASSISTANT USED THE DA VINCI ENDOSCOPE TO SEARCH FOR THE FRAGMENT AND USED THE LAPAROSCOPIC INSTRUMENT TO GRASP THE FRAGMENT AND PULL IT OUT. NO POST-OPERATIVE TESTS WERE PERFORMED TO CHECK FOR ANY REMAINING FRAGMENTS. NO ISSUES WERE OBSERVED WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE PROCEDURE. THE SURGEON DID NOT EXPERIENCE ANY ISSUES WITH REMOVING THE INSTRUMENT PRIOR TO THE BREAKAGE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE PROCEDURE. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPE

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 DURING A DA VINCI-ASSISTED TOTAL HYSTERECTOMY SURGICAL PROCEDURE, THE SURGEON NOTED THAT THE SYNCHROSEAL INSTRUMENT ARCED AT THE JAWS. THE SURGEON BELIEVED THAT IT WAS TRIGGERED BY A THICK, ROUND, LIGAMENT OF TISSUE. THE GENERATOR DID NOT SHUT OFF DUE TO THE REPORTED ARCING INCIDENT, BUT DAMAGE WAS NOTED BETWEEN THE JAWS OF THE INSTRUMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY WITH NO REPORTED INJURY OR ADVERSE CONSEQUENCE TO THE PATIENT. ON (B)(6) 2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE SURGEON, REGARDING THE REPORTED EVENT: THE SURGEON CONFIRMED THAT THE SYNCHROSEAL INSTRUMENT WAS INSPECTED AT THE BEGINNING OF THE CASE AND NO DAMAGE WAS NOTED. THE ARCING EVENT WAS NOTED AFTER ABOUT FIVE MINUTES OF USE. THE SURGEON BELIEVED THAT THE ARCING EVENT OCCURRED DUE TO THE JAWS NOT CLOSING COMPLETELY ON A THICKER PORTION OF TISSUE. THE SURGEON CONFIRMED THAT THE INSTRUMENT WAS NOT REMOVED ANY TIME PRIOR TO THE ARCING EVENT. UPON REMOVAL, THE WRIST OF THE INSTRUMENT WAS STRAIGHTENED. THE SURGEON CONFIRMED THAT THERE WAS NO PATIENT HARM, INJURY OR ADVERSE OUTCOME DUE TO THE REPORTED ARCING INCIDENT. THE SURGE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL INTO THE PATIENT AND WAS RETRIEVED IN THE SAME PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT FOUR PEDICLE SCREWS WERE NOT PLACED ACCORDING TO THE SCREW PLAN USING THE, EXCELSIUS GPS SYSTEM, AT THE L3-4 LEVEL. INTRA-OPERATIVE IMAGING SHOWED THAT THE TWO LEFT SCREWS WERE PLACED MEDIALLY AND THE TWO RIGHT SCREWS WERE PLACED LATERALLY. THE SCREWS WERE REMOVED AND PLACED WITHOUT USE OF THE SYSTEM.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

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 AFTER UNDERGOING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, A FEMALE PATIENT IN HER 70'S HAD AN ULTRASONOGRAPHY PROCEDURE PERFORMED ON THE VEINS IN A LOWER LIMB, IN ADDITION TO A ECHOCARDIOGRAPHY PROCEDURE AS A RESULT OF ELEVATED LEVELS OF SOLUBLE FIBRIN AND D-DIMER IN HER POST-OPERATIVE DAY #1 BLOOD SAMPLING. DEEP VEIN THROMBOSIS (DVT) WAS FOUND AND THE PATIENT WAS ALSO SUSPECTED TO HAVE A PULMONARY EMBOLISM. AS A RESULT, THE PATIENT WAS TREATED WITH ANTICOAGULANT THERAPY AND DISCHARGED ONE WEEK POST-OPERATIVELY. THE HOSPITAL COMMENTED THAT IT IS UNKNOWN IF THE POST-OPERATIVE COMPLICATIONS WERE DIRECTLY RELATED TO THE ROBOTIC SURGERY. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ON 21-MAY-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE SURGICAL PROCEDURE WAS RECORDED ON VIDEO. HOWEVER, THE VIDEO IS NOT AVAILABLE FOR ISI TO REVIEW. NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. THERE WERE NO CONVERSIONS TO TRADITIONAL LAPAROSCOPIC OR OP

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 BY A PROFESSOR OF RESPIRATORY SURGERY THAT A PATIENT UNDERWENT AN UNSPECIFIED UROLOGICAL DA VINCI-ASSISTED SURGICAL PROCEDURE ON AN UNSPECIFIED DATE. THE PROFESSOR INDICATED THAT THE PATIENT DIED FROM AN AIR EMBOLISM AS A RESULT OF USING AN AIR SEAL (A 3RD PARTY MANUFACTURER DEVICE) BY INCREASING THE PRESSURE TO INCREASE THE HEMOSTATIC EFFECT. ON 12-MAR-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE ISI CLINICAL SALES REPRESENTATIVE (CSR) REPORTEDLY HEARD THAT THE RESPIRATORY SURGEON HAD CONDUCTED THE DA VINCI-ASSISTED UROLOGICAL PROCEDURE. THE SURGICAL PROCEDURE WAS RECORDED ON VIDEO. HOWEVER, IT IS UNKNOWN IF THE VIDEO IS AVAILABLE FOR ISI TO REVIEW. THERE WERE NO REPORTED INTRA-OPERATIVE COMPLICATIONS. NO FURTHER CLINICAL OR PATIENT INFORMATION WAS PROVIDED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

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 AT THE CONCLUSION OF A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, A BURN INJURY TO THE SKIN ON THE PATIENT'S SACRUM WAS IDENTIFIED. ALTHOUGH THE BURN SEVERITY (DEGREE) WAS UNKNOWN, IT WAS NOTED THAT THE PATIENT DID NOT RECEIVE ANY MEDICAL INTERVENTION DUE TO THE BURN INJURY. THE SURGEON/SITE DOES NOT BELIEVE AN INTUITIVE SURGICAL, INC. (ISI) PRODUCT CAUSED OR CONTRIBUTED TO THE ALLEGED BURN INJURY. THE CUSTOMER REPORTEDLY USES SINGLE-USE DUAL-BLADE NEUTRAL PLATES (GROUNDING PADS) FOR COAGULATION, PLACING IT ON LEFT LEG FROM ABOVE. ON 07-APR-2020, ISI FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING INFORMATION: THE SKIN INTEGRITY OF THE PATIENT WAS NORMAL. IT WAS NOT THIN OR FRAIL. THE PATIENT HAD NO PRE-EXISTING SKIN CONDITIONS. IT WAS CONFIRMED TO BE A BURN INJURY TO THE PATIENT'S SACRUM. IT WAS A 1ST-2ND DEGREE BURN. THE BURN INJURY WAS REPORTED TO BE "10X20SM, RECTANGULAR, RED, WITH BLISTERS. THE PATIENT RECEIVED LOCAL SKIN TREATMENT AND WOUND DRESSING. THE SURGEON BELIEVED THAT THE BURN INJURY WAS DUE TO ¿NOT PROPER ISOLATION OF THE OPERATING TABLE.¿ THE GROUNDING PAD WAS CORRECTLY PLACED ON THE PATIENT'S LEFT LEG. IT WAS INSPECTED BEFORE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON OR ABOUT (B)(6) 2020, A MAKO TOTAL KNEE WITH TRIATHLON WAS IMPLANTED INTO THE PATIENT'S RIGHT KNEE USING PRODUCT/ROBOTIC ASSISTANCE, PINNING THE PRODUCT TO THE PATIENT'S FEMUR. IT IS FURTHER ALLEGED THAT ON OR ABOUT (B)(6) 2020, THE PATIENT'S FEMUR BROKE AS A DIRECT RESULT OF THE PRODUCT AND IMPLANTATION, AND HE UNDERWENT SUBSEQUENT SURGERY AS A RESULT OF HIS INJURIES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE COMPLAINANT, VAIDA NAUSEDIENE, REPORTED THAT ON DAY 4, THE PATIENT DEVELOPED FEVER, SIGNS OF PERITONITIS. THE ADVERSE EVENT WAS AN ANASTOMOTIC LEAKAGE. ON (B)(6) 2020, PATIENT WAS RE-OPERATED VIA LAPAROTOMY, DISRUPTION OF ANASTOMOSIS, LAVAGE AND DRAINAGE OF THE ABDOMEN, END COLOSTOMY. PATIENT WAS THEN TREATED IN ICU, THUS POSTOPERATIVE COURSE AND RECOVERY WAS LONGER DUE TO INFECTION OF THE LAPAROTOMY WOUND, WITH OBESITY AND CO-MORBIDITIES PRESENT. PATIENT RECOVERED AND WAS DISCHARGED FOR A 20-MARCH-2020 DATE OF RESOLUTION. THIS EVENT DID NOT OCCUR WITHIN THE U.S. THE EVENT OCCURRED IN (B)(6) HOSPITAL IN LITHUANIA. ADDITIONALLY, THIS EVENT OCCURRED ON 29-FEBRUARY-2020, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 16-AUGUST-2023.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT FOUR PEDIC/E SCREWS WERE NOT PLACED ACCORDING TO THE SCREW PLAN. INTRA-OPERATIVE IMAGING SHOWED THE SCREWS WERE PLACED MEDIALLY AND WERE OFF BY TWO VERTEBRAL LEVELS. THE SCREWS WERE REMOVED AND NEW ANTERIOR, POSTERIOR, AND LATERAL C­ ARM IMAGES WERE REGISTERED AND MERGED. USING THE EXCELSIUS GPS, THE SCREWS WERE CORRECTLY PLACED AT LS AND S1 ACCORDING TO THE INITIAL 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: REFER TO FOR FOLLOW-UP INFORMATION.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MAKO ROBOTIC EQUIPMENT MADE INCORRECT POSTERIOR CHAMBER CUT DURING SURGERY. FDA SAFETY REPORT ID# (B)(4).

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THE LEFT LS SCREW WAS PLACED LOW TO PLAN. THE SCREW WAS REPOSITIONED INTRA-OPERATIVELY TO A NEW TRAJECTORY USING FLUOROSCOPIC IMAGING. IMMEDIATELY POST-OPERATIVE THE PATIENT HAD LIMITED MOVEMENT TO THE LOWER LEG AND FOOT. 28 DAYS LATER, THE SURGEON REPORTED THAT THE PATIENT HAD STARTED TO RECOVER MOVEMENT AND BELIEVED THIS IMPROVEMENT WOULD CONTINUE.