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 SLEEVE GASTRECTOMY SURGICAL PROCEDURE, A ¿SMALL RIVET¿ FROM THE SYNCHROSEAL INSTRUMENT FELL INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED DURING THE SAME PROCEDURE AND THE SURGEON DISCONTINUED USING THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION ON 28-JULY-2021. THE INSTRUMENT WAS NOT INSPECTED PRIOR TO USE. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT WAS USED FOR APPROXIMATELY 10 MINUTES. THE SURGEON WAS DISSECTING BY THE HIATUS WHEN THE INSTRUMENT BROKE. THE BROKEN FRAGMENT WAS RETRIEVED BY USING A LAPAROSCOPIC GRASPER. ALL FRAGMENTS WERE RETRIEVED AND IT WAS CONFIRMED VISUALLY. NO POST-OPERATIVE TESTS WERE PERFORMED.

Monarch Platform — 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 A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE PNEUMOTHORAX WAS DISCOVERED DURING THE POST-OP CHEST X-RAY. THE LOCATION OF THE TARGET WAS RIGHT UPPER LOBE. A CHEST TUBE WAS PLACED, AND PATIENT WAS HOSPITALIZED. THE CHEST TUBE WAS REMOVED, AND THE PATIENT WAS DISCHARGED ON (B)(60 2021.

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.

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 A SCREW WAS MISPLACED AT THE LEFT L5 DUE TO PATIENT MOVEMENT RESULTING IN A DURAL TEAR, WHICH WAS REPAIRED INTRA-OPERATIVELY.

Monarch Platform — 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 A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, PATIENT EXPERIENCED A PNEUMOTHORAX. THE BIOPSY OF A LESION IN THE RIGHT MIDDLE LOBE. THE LOCATION OF THE PNEUMOTHORAX WAS RIGHT SIDE. A CHEST TUBE WAS PLACED TO TREAT THE PNEUMOTHORAX. THE PATIENT WAS RELEASED THE SAME DAY.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT TWO WEEKS AFTER AN L3-L5 PROCEDURE, THE PATIENT EXPERIENCED FOOT DROP SYMPTOMS. AFTER IMAGING, THE RIGHT L4 SCREW WAS FOUND TO BE MEDIAL BY 4-5 MM. THE MANUFACTURER REPRESENTATIVE STATED THAT THE PATIENT HAD HIGH BMI AND THERE WAS SOFT TISSUE PRESSURE ON THE TOOLS DURING THE PROCEDURE. THERE WAS NO SKIVE POTENTIAL IN THE PLANNING FOR THE TRAJECTORIES. A REVISION PROCEDURE TO REPOSITION THE SCREW USING NAVIGATION WAS PLANNED. THERE WAS NO DELAY TO THE 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: INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A CUREUS JOURNAL ARTICLE TITLED, ¿USE OF BARIATRIC PORTS IN 4-ARM ROBOTIC PARTIAL NEPHRECTOMY: A COMPARATIVE STUDY WITH THE STANDARD 3-ARM TECHNIQUE¿ (EL-ASMAR, J. M., SEBAALY, R., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, POST-OPERATIVE COMPLICATIONS INVOLVING A DA VINCI SURGICAL PROCEDURE WERE NOTED: "TWO PATIENTS REQUIRED POSTOPERATIVE SELECTIVE ARTERIAL EMBOLIZATION FOR POSTOPERATIVE BLEEDING/ HEMATOMA." ISI CONTACTED THE AUTHOR CORRESPONDENCE WHO CONFIRMED THAT THESE CASES WERE PERFORMED IN THEIR CENTER. THE AUTHOR CORRESPONDENCE INDICATED THAT NONE OF THE COMPLICATIONS IN QUESTION WERE DUE TO A SYSTEM MALFUNCTION AND "THESE OCCURRENCES ARE EXPECTED COMPLICATIONS AFTER PARTIAL NEPHRECTOMY AND ARE INHERENT TO THIS TYPE OF SURGERY WHATEVER THE APPROACH OPEN, LAPAROSCOPIC OR ROBOTIC."

the collision of three bots on the grid resulting in a fire.

Mi-brand WRJTZ02FM drone 4K kit — 4,000 units manufactured between 8 and 18 Feb 2017 recalled because flight-control software parameters were set wrong, so the aircraft could lose power and fall during extreme high-altitude flight. Fixed by an over-the-air firmware update. Filed with SAMR under China's Interim Provisions on Consumer Product Recall Management.

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 HARMONIC ACE WAS IN USE FOR 30 MINUTES AND A FRAGMENT FROM THE TEFLON PAD WAS FOUND TO BE MISSING. THE CUSTOMER STATED THAT THE WHITE FRAGMENTS FELL INSIDE THE PATIENT WHEN ACTIVATING THE ENERGY. A SIMILAR BACKUP DA VINCI INSTRUMENT WAS USED TO CONTINUE. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT HARM, ADVERSE OUTCOME, OR INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. THE INSTRUMENT WAS IN USE FOR ABOUT 30 MINUTES AND BROKE WHILE IT WAS BEING USED FOR DISSECTING TISSUE. ALL THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE AND CONFIRMED WITH VISUAL INSPECTION. THE SURGEON BELIEVED THE WHITE PART OF THE TIP MELTED WHEN ENERGY WAS ACTIVATED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY HARD MATERIALS OR OTHER INSTRUMENTS. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE)

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 LOW ANTERIOR RESECTION SURGICAL PROCEDURE, A PIECE OF THE WHITE MATERIAL, REPORTED TO BE ABOUT 0.5 MM WAS MISSING FROM INSIDE THE JAW OF THE SYNCHROSEAL. THE SURGEON REPORTEDLY DECIDED TO CONTINUE USING THE PRODUCT, AND FELT THAT SINCE THE MISSING PART WAS VERY SMALL THAT THEY WOULD NOT BE ABLE TO FIND THE MISSING PART. IT WAS UNKNOWN WHETHER THE MISSING FRAGMENT HAD FALLEN INSIDE THE PATIENT OR ELSEWHERE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 27-JULY-2021: IT WAS UNKNOWN IF ANY FRAGMENT FELL INSIDE THE PATIENT AND UNKNOWN IF ANY FRAGMENT WAS RETRIEVED. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WAS PERFORMED TO CHECK FOR RETAINED FRAGMENTS. THE PROCEDURE HAD BEEN IN PROCESS FOR 4 HOURS AND THE SYNCHROSEAL INSTRUMENT WAS IN USE FOR ABOUT 20 MINUTES. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS FOUND. THE SURGEON DID NOT NOTICE ANY ISSUE WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE SURGEON DOES NOT KNOW WHAT CAUSED THE ISSUE TO OCCUR. IT WAS UNKNO

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PROGRASP INSTRUMENT HAD A FRACTURED WIRE IN ITS CABLE SYSTEM. FDA SAFETY REPORT ID # (B)(4).

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: ON (B)(6) 2021, THE SUBJECT (B)(6) UNDERWENT ROBOTIC-ASSISTED LOWER ANTERIOR RESECTION WITH HANDSEWN COLO-ANAL ANASTOMOSIS USING THE DA VINCI SP SURGICAL SYSTEM WITH DIVERTING LOOP ILEOSTOMY. AFTER DOCKING THE SP ROBOT, A SECONDARY PORT FOR THE STAPLING DEVICE WAS UTILIZED IN THE RIGHT LOWER QUADRANT. IT WAS NOTED THAT THE PROCEDURE WAS SUBSTANTIALLY MORE DIFFICULT BECAUSE OF SIGNIFICANT DIFFICULTY WITH MOBILIZING AND IDENTIFYING ANATOMICAL STRUCTURES DUE TO THE ALTERED SURGICAL FIELD SECONDARY TO INFLAMMATION AND TISSUE FRIABILITY LIKELY DUE TO HIS PREVIOUS HEMATOLOGICAL MALIGNANCY AND CURRENT THERAPY. THE TUMOR WAS LOCATED WITHIN A FINGER BREADTH OF THE ANAL CANAL AND DISSECTION AROUND THIS TUMOR NECESSITATED HANDSEWN COLO-ANAL ANASTOMOSIS WHICH WAS DONE WITH A STANDARD MUCOSECTOMY. THE SPECIMEN WAS DELIVERED THROUGH THE ANAL CANAL AND THEN SEWN TO THE DESCENDING COLON WITH VICRYL SUTURES. THE ANASTOMOSIS WAS EVALUATED AND FOUND TO BE VIABLE. A SINGLE DRAIN WAS LEFT IN THE DEEP PELVIS. THE TERMINAL ILEUM WAS IDENTIFIED AND BROUGHT OUT OF THE ILEOSTOMY SITE. CLOSURE OF THE SITE WAS COMPLETED. THE SUBJECT DID NOT EXPERIENCE ANY INTRAOPERATIVE COMPLICATIONS, AND THERE WAS NO CONVERS

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT FLUORO IMAGES WERE TAKEN DURING THE PROCEDURE AND THE SURGEON CONFIRMED ACCURACY. NO PROBLEMS WERE EXPERIENCED DURING THE INITIAL PROCEDURE. THE CAUSE OF THE DEVIATION WAS DETERMINED TO BE A MEDIAL SKIVE POTENTIAL AND A DRILL BIT TAKING THE PATH OF LEAST RESISTANCE DOWN THE JOINT. THE PATIENT EXPERIENCED FOOT DROP AFTER THE 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE TIP OF THE SYNCHROSEAL INSTRUMENT FELL INSIDE THE PATIENT. THROUGH FOLLOW UP, IT WAS CONFIRMED THAT THE SURGEON WAS ABLE TO RETRIEVE ALL OF THE BROKEN FRAGMENTS DURING THE SAME PROCEDURE, THERE WERE NO INSTRUMENT COLLISIONS, AND THE PATIENT HAS NOT RETURNED WITH ANY POST-OPERATIVE COMPLICATIONS.

Monarch Platform — 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 A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, PATIENT EXPERIENCED A PNEUMOTHORAX. THE PNEUMOTHORAX WAS DISCOVERED DURING POST-OP CHECK VIA A CHEST X-RAY. THE LOCATION OF THE TARGET AND PNEUMOTHORAX WAS LEFT LOWER LOBE. THE PNEUMOTHORAX WAS A 30-40%. A CHEST TUBE WAS PLACED AND THE PATIENT WAS RELEASED THE SAME DAY.

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 BY AN UNSPECIFIED SURGEON, NOT THE CONSOLE SURGEON OF RECORD, THAT THERE WAS A REPORT OF A PATIENT DEATH OCCURRING ON AN SP DA VINCI SYSTEM. ADDITIONAL EVENT DETAILS (INCLUDING THE DATE OF THE EVENT), PATIENT DEMOGRAPHICS, PATIENT DATE OF DEATH, AND SYSTEM AND/OR PROCEDURE DETAILS WERE UNKNOWN AND UNATTAINABLE EVEN AFTER ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION. INTUITIVE SURGICAL, INC. (ISI) HAS REACHED OUT TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SUBJECT 600-02 (HEREAFTER REFERRED TO AS THE SUBJECT) UNDERWENT ROBOTIC-ASSISTED LOWER ANTERIOR RESECTION WITH THE DA VINCI SP SURGICAL SYSTEM ON (B)(6) 2021. ON (B)(6) 2021, THE SUBJECT MET ALL STUDY ELIGIBILITY CRITERIA AND SIGNED THE INFORMED CONSENT. THE SP SYSTEM WAS DOCKED AFTER CREATION OF THE SP PORT AND THE ILEOSTOMY PORT. ONCE THE RECTUM WAS TRANSECTED WITH THE LAPAROSCOPIC STAPLER, THE SPECIMEN WAS DELIVERED THROUGH THE WOUND PROTECTING DEVICE IN THE SP PORT. THIS WAS THEN RESECTED AND A PROLENE PURSE STRING WAS UTILIZED TO ENTER THE ANVIL INTO THE DESCENDING COLON. AFTER THIS WAS SECURED AND REPLACED BACK INTO THE ABDOMEN, THE ABDOMEN WAS REINSUFFLATED WITH THE SP ROBOTIC DEVICE AND THE ANASTOMOSIS WAS CREATED. PROCTOSCOPIC AND FINGER EXAMINATION OF THE ANASTOMOSIS REVEALED THIS TO BE INTACT. A SECTION OF THE TERMINAL ILEUM WAS IDENTIFIED NEAR THE CECUM FOR THE DIVERTING LOOP ILEOSTOMY WHICH WAS PULLED THROUGH THE ILEOSTOMY SITE. THE SP PORT WAS REMOVED, THE SITE WAS THEN CLOSED, NO DRAINS WERE PLACED. THE ILEOSTOMY WAS THEN CREATED. THE SUBJECT DID NOT EXPERIENCE ANY INTRAOPERATIVE COMPLICATIONS, AND THERE WAS NO CONVERSION TO OPEN SURGERY, ROBOTIC MULTIPORT OR LAPAROS

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 REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE MAIN MACHINE OF THE ULTRASONIC KNIFE WAS REPORTING THAT THE PRESSURE OF THE KNIFE HEAD WAS TOO LARGE. DURING THE OPERATION, THE PATIENT SUFFERED FROM "A LOT OF BLEEDING." THE NURSE PULLED OUT THE ULTRASONIC KNIFE FOR RE-TESTING, AND THE MAIN MACHINE OF THE ULTRASONIC KNIFE SUGGESTED THAT THE INSTRUMENT SHOULD BE REPLACED. THE PROCEDURE WAS COMPLETED WITH A BACKUP DA VINCI INSTRUMENT OF THE SAME KIND, AND THERE WAS NO REPORTED INJURY. ON 15-JULY-2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISI CLINICAL SALES REPRESENTATIVE (CSR) CLARIFIED THAT THE PROMPT INDICATING EXCESS PRESSURE ON THE HARMONIC ACE INSTRUMENT DISPLAYED AFTER ONE HOUR, DURING THE PROCEDURE. THERE WAS NO ALLEGATION THAT THE INSTRUMENT CAUSED OR CONTRIBUTED TO THE BLEEDING. THE BLEEDING WAS COMING FROM THE LIVER TISSUE. THERE WAS APPROXIMATELY LESS THAN 800ML OF BLOOD LOSS. NO INFORMATION WAS PROVIDED REGARDING THE CAUSE OF THE BLEEDING. THE CUSTOMER HAD TO ADMINISTER OR TRANSFUSE 400ML OF BLOOD. NO INFORMATION WAS PROVIDED REGARDING IF THE PATIENT HAD RETURNED TO THE HOSPITAL DUE TO POST

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON FOUND THE MONOPOLAR SCISSOR TIP WAS MISSING. THE CALLER FORWARDED A PICTURE SHOWING THAT THE TIP AND THE COUPLER WERE MISSING FROM THE MONOPOLAR SCISSOR. AT THE TIME OF THE CALL THE STAFF WAS UNABLE TO LOCATE THE COUPLER. THE STAFF REPLACED THE MONOPOLAR SCISSOR TIP AND WERE PROCEEDING WITH THE PROCEDURE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICES ENGINEER (TSE) EXPLAINED THE COUPLER IS RADIOLUCENT. THE REPORTER EXPLAINED SHE WOULD FOLLOW UP WITH ANY FURTHER DETAILS AS SHE RECEIVED THEM. THE TSE RECOMMENDED THE STAFF RMA THE MISSING MONOPOLAR SCISSOR TIP FOR FAILURE ANALYSIS. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION ON 01-JULY-2021: THIS WAS A MONOPOLAR SCISSOR TIP SINGLE PORT (SP) INSTRUMENT SO IT WAS THE PLASTIC PORTION THAT GOES OVER THE SCREWS AND THE ACTUAL TIP THAT FELL IN THE PATIENT. THE PIECES WAS RETRIEVED AT THE END OF THE PROCEDURE. WE HAVE REQUESTED TO SEND BACK THE INSTRUMENT AND THE BROKEN PIECES BACK TO ISI. SHE WAS NOT IN THE PROCEDURE, BUT SAID THE ROBOTICS

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: I HAD WHAT WAS SUPPOSED TO BE A ROUTINE GALLBLADDER REMOVAL. I SPENT THREE DAYS IN AN (B)(6) HOSPITAL, WENT HOME FOR TWO DAYS, AND SPENT AN ADDITIONAL TWO DAYS IN ANOTHER (B)(6) HOSPITAL. I EXPERIENCED BLEEDING AT A WOUND SITE (POST-SURGERY) THAT REQUIRED THREE BLOODIED DRESSING CHANGES AND SUTURING AT THE BLEEDING WOUND SITE. I WAS RELEASED FOR THE FIRST HOSPITAL, WITH A FOLEY BAG THAT WAS INSERTED ON FOUR DIFFERENT OCCASIONS, BUT NEVER SAW A UROLOGIST IN THE HOSPITAL. THE DAY AFTER DISCHARGE, I BEGAN TO BLEED, ONCE AGAIN, AT THE SUTURED WOUND SITE. I WENT TO THE LOCAL (B)(6) EMERGENCY TO HAVE THE WOUND CLEANED AND REDRESSED. TWO DAYS LATER, I CALLED A UROLOGY OFFICE NOTED IN MY DISCHARGE INSTRUCTIONS AND WAS TOLD THEY COULD NOT SEE ME FOR TWO WEEKS. I WENT BACK TO THE LOCAL (B)(6) EMERGENCY ROOM TO HAVE THE CATHETER REMOVED. THEY PERFORMED ADDITIONAL TESTS AND SAID I WAS BLEEDING INTERNALLY AND HAD POCKETS OF BLOOD IN THREE LOCATIONS IN MY ABDOMEN AND RUSHED ME TO A DIFFERENT (B)(6). A PHYSICIAN, WHO IDENTIFIED HIMSELF AS PART OF THE SURGICAL TEAM, SAID HE WANTED ME TO STAY IN THE HOSPITAL, OVERNIGHT, TO MONITOR MY HEMOGLOBIN LEVEL. I ASKED THE "SURGICAL TEAM" PHYSICIAN TO ARRANG

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 BY SALE REP THAT THERE WAS AN ACCIDENT IN MAKO TKA CASE AT SIPH ((B)(6) 2021 ) WHICH SURGEONS OF THIS CASE FOUND SOME FRACTURE OF POSTERIOR CONDYLE OF FEMUR AFTER DONE IN EVERY STEP OF BONE CUT AFFECTED TO FEMUR PROSTHESIS WHICH CAN NOT PLACE IN THERE. IT MAY BE OCCURRED FROM SOFT BONE OR TOO BIG HOUSING CUTTING BLOCK FOR SIZE 2 OF FEMUR PROSTHESIS. SO THEY ASK FOR CONSTRAIN PROSTHESIS WITH STEM TO USE REPLACED BUT WE HAVEN¿T PREPARE WITH THIS CASE BECAUSE THIS IS PRIMARY CASE. HOWEVER SURGEONS ASK FOR SUPPORT FROM ZIMMER COMPANY AND THE OPERATION WAS COMPLETELY DONE. SURGICAL DELAY 2 HOURS

Mazor system (model not stated) — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SPINAL FUSION COMPLETED USING MAZOR ROBOT. SCREWS WERE PLACED PER DIRECTION OF MAZOR ROBOT. AFTER SURGERY, PT FOUND TO HAVE MALPOSITIONED SCREWS RESULTING IN PT INJURY.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE SURGICAL ARM HIT THE BONE MOUNT BRIDGE DURING REGISTRATION. AN AP IMAGE WAS TAKEN AND THE BRIDGE WAS HIT WHEN MOVING THE SURGICAL ARM TO THE OBLIQUE POSITION. THE 3D MARKER WAS REMOVED FROM THE ARM GUIDE PRIOR TO THE SURGICAL ARM BEING SENT TO THE OBLIQUE TRAJECTORY. A NAVIGATION ACCURACY TEST WAS DONE AFTER THE ANATOMICAL ACCURACY TEST. THE PASSIVE PLANAR PROBE WAS USED AND PLACED ON THE PATIENT'S ANATOMY AND THEN THE ARM GUIDE. ADDITIONAL ANATOMICAL CHECKS WERE DONE THROUGHOUT THE CASE SINCE AN INSTRUMENT WAS SHOWN TO BE SLIGHTLY MEDIAL DURING THE PROCEDURE. NAVIGATION ACCURACY AND GUIDANCE SYSTEM ACCURACY WERE DISCUSSED WITH THE SURGEON. THE SURGEON DECIDED TO DO ADDITIONAL SNAPSHOTS AND ACCURACY TESTS WERE PERFORMED AFTERWARDS TO AVOID RE-REGISTERING THE PATIENT. THE ADDITIONAL ANATOMICAL ACCURACY CHECKS WERE ACCURATE. THE REVISION PROCEDURE WAS COMPLETED. AFTER THE PROCEDURE, THE PATIENT STILL HAD WEAKNESS AND IMMOBILITY ON THEIR LEFT SIDE.

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 REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY CAME OFF THE MCS INSTRUMENT. IT WAS NOTED THAT THEY "FLIPPED BETWEEN ROBOT TO OPEN TO LAP SEVERAL TIMES" FOR THE PROCEDURE AND THAT DURING ONE OF THE TRANSITIONS THEY NOTICED THAT THE MCS TIP COVER ACCESSORY WAS MISSING. THE CUSTOMER WAS ASKING IF THE ITEM WAS DETECTABLE VIA X-RAY OR CT SCAN. THE CUSTOMER LATER FOLLOWED UP TO LET US KNOW THAT THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE, AND THAT THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP ON 21-JUNE-2021. THE CUSTOMER WAS UNABLE TO SPECIFY AT WHAT POINT THE MCS TIP COVER ACCESSORY HAD FALLEN OFF OF THE INSTRUMENT. NO FURTHER DETAILS WERE AVAILABLE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SURGEON SENT A SCREENSHOT, THAT HE COULD NOT LOAD A CT FROM PACS. THE SURGERY WAS PERFORMED CONVENTIONALLY (WITHOUT THE USE OF THE ROBOT), BECAUSE IT WAS NOT POSSIBLE TO LOAD IMAGES.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A PATIENT WITH A HISTORY OF LUPUS AND A RECENT BRONCHOSCOPY FOR A BIOPSY OF THE LEFT LUNG NODULE RETURNED TO THE HOSPITAL THE FOLLOWING MORNING FOR PAIN IN THE LEFT CHEST AND REQUESTED A CHEST X-RAY FOR FURTHER EVALUATION. THE PATIENT DENIES SHORTNESS OF BREATH BUT REPORTS INCREASED PAIN WITH DEEP BREATHING. THE PATIENT DID HAVE A POST PROCEDURE X-RAY DONE FOLLOWING THE PROCEDURE WHICH SHOWED NO PNEUMOTHORAX. THE PATIENTS PAIN STARTED ON THE WAY HOME FROM THE PROCEDURE THE PREVIOUS DAY. A THORA VENT WAS PLACED INTO THE LEFT CHEST. SUCTIONING WAS USED FOR ABOUT AN HOUR. A REPEAT X-RAY AT THAT TIME SHOWED NEAR COMPLETE RESOLUTION OF THE PNEUMOTHORAX ON THE LEFT. THE PATIENT CONTINUED TO FEEL WELL AND WAS NOT HOSPITALIZED. THE PATIENT RETURNED THE FOLLOWING DAY TO HAVE THE THORA VENT REMOVED AND REPORTED TOLERATED THE DEVICE WELL, NO SHORTNESS OF BREATH AS WELL AS NO SIGNIFICANT LEFT CHEST PAIN.

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.

At 9:30 a.m. on June 12, 2021, Employee #1 was working on an automated guided vehicle (AGV) when a second AGV approached and struck him in the leg with its forks. The employee sustained a broken leg and was hospitalized for treatment.

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, "MOST RECENTLY WAS AN ISSUE WITH THE NEW SYNCHROSEAL INSTRUMENT, PATIENT SAFETY CONCERN WITH BROKEN PIECE." THERE WAS NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY. CUSTOMER FEEDBACK RELATED TO AN INTUITIVE SURGICAL, INC. (ISI) PRODUCT WAS RECEIVED VIA A BLIND SURVEY. ISI IS UNABLE TO PERFORM FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION DUE TO THE NATURE OF HOW THIS INFORMATION WAS COLLECTED. NO PRODUCT, REPORTER, OR SITE INFORMATION WAS AVAILABLE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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 REPORTED THAT AFTER A DA VINCI-ASSISTED RIGHT PULMONARY LOBECTOMY PROCEDURE, THE PATIENT DEVELOPED A POSTOPERATIVE CHYLOTHORAX. THE SURGEON COMMENTED THAT THE SEALING OF THE SYNCHROSEAL MAY BE UNSATISFACTORY. THE PATIENT WAS HOSPITALIZED AND UNDER OBSERVATION. IT IS UNKNOWN IF ANY MEDICAL/SURGICAL INTERVENTION WAS TAKEN. THE PROCEDURE WAS COMPLETED AS PLANNED. ON (B)(6) 2021, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ISI CLINICAL SALES REPRESENTATIVE (CSR), WHO SPOKE TO THE CUSTOMER, AND OBTAINED THE FOLLOWING INFORMATION: THE SYSTEM, INSTRUMENT AND ACCESSORY WERE INSPECTED BEFORE USE AND THERE WAS NOTHING OUT OF THE ORDINARY. THERE WAS NO MALFUNCTION OF AN ISI SYSTEM, INSTRUMENT OR ACCESSORY THAT OCCURRED. THERE WAS NO EVIDENCE OF INSUFFICIENT SEALING/CAUTERY ISSUE/INTRA-OPERATIVE COMPLICATION OBSERVED DURING THE PROCEDURE AND THE SURGERY WAS COMPLETED AS PLANNED. THERE WAS NO UNEXPECTED BLEEDING OBSERVED DURING THE PROCEDURE. THE CUSTOMER CONFIRMED THAT THE TISSUE BUNDLE WAS LESS THAN 5 MM, THE TISSUE FIT IN THE JAWS OF THE INSTRUMENT, THERE WAS NO TISSUE TENSION, NO CONTACT WITH HARD MATERIAL, NO EVIDENCE OF VESSEL CALCIFICATION AND THE INSTRUMENT JAWS WERE NOT

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 DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE WAS FOUND TO HAVE A MELTED TEFLON PAD. FRAGMENTS FROM THE INSTRUMENT REPORTEDLY FELL INSIDE THE PATIENT DURING AN INSTRUMENT TIP OR ACCESSORY COLLISION AND WERE "VERY HARD TO BE RETRIEVED." THE SURGEON RETRIEVED THE FRAGMENTS WITH A BACKUP INSTRUMENT AND NOTED CONCERN ABOUT THE QUALITY OF THE TEFLON PAD. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT HARM, ADVERSE OUTCOME, OR INJURY. THE FRAGMENTS ARE NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE IDENTIFIED. THE INSTRUMENT WAS IN USE FOR APPROXIMATELY 10 TO 20 MINUTES BEFORE THE ISSUE. ALL THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE AND CONFIRMED WITH VISUAL INSPECTION. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. IT WAS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR. THE REPORTER NOTED THAT THE INSTRUMENT DID NOT COLLIDE WITH ANY HARD MATERIALS OR OTHER INSTRUMENTS AS WAS INITIALLY REPORTED. THERE WAS NO PATIENT INJURY

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INTUITIVE SURGICAL INC. (ISI) BECAME AWARE OF A EUROPEAN UROLOGY OPEN SCIENCE ARTICLE TITLED, ¿SALVAGE VERSUS PRIMARY ROBOT-ASSISTED RADICAL PROSTATECTOMY: A PROPENSITY-MATCHED COMPARATIVE EFFECTIVENESS STUDY FROM A HIGH-VOLUME TERTIARY CENTRE¿ (NATHAN, A., FRICKER, M., ET AL., 2021). WITHIN THE CLINICAL JOURNAL ARTICLE, IT WAS CITED -ONE PATIENT SUFFERED FROM A HEMATOMA REQUIRING REOPERATION AND WASHOUT AFTER HIFU THERAPY. ON 15-JUN-2021, ISI OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE AUTHOR REGARDING THE REPORTED EVENT: IT WAS REPORTED THAT THE DURING PORT INCISION, THERE WAS A VESSEL (VEIN) INJURY. AS A RESULT, THE PATIENT EXPERIENCED A HEMATOMA. THE ESTIMATED BLOOD LOSS INTRA-OPERATIVELY WAS 250-500MLS. THERE WAS PROCEDURE FOR A WASHOUT AND HEMOSTASIS. THERE WAS NO BLOOD TRANSFUSION ADMINISTERED TO THE PATIENT. THE SURGEON HAD CONFIRMED THERE WAS NO RELATION TO THE DA VINCI PRODUCT. HOWEVER, IT IS UNKNOWN IF THE TROCAR WAS AN ISI PRODUCT OR A THIRD-PARTY PRODUCT. AT THIS TIME, IT WAS UNCONFIRMED AS TO WHETHER A DA VINCI SURGICAL SYSTEM WAS INVOLVED IN THE REPORTED EVENT AND THERE IS NO KNOWN ALLEGATION OF A MALFUNCTION OF A DA VINCI PRODUCT.

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 A DA VINCI ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE BLEEDING AND REQUIRED HOSPITALIZATION IN THE ICU. THE SURGEON SAID HE NO LONGER WILL USE THE SYNCHROSEAL INSTRUMENT. INTUITIVE SURGICAL INC. (ISI) CONTACTED THE SURGEON WHO PERFORMED THIS PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE EVENT: THE PROCEDURE OCCURRED IN JUNE BUT THE EXACT DATE WAS NOT PROVIDED. THE PROCEDURE WAS PERFORMED ON A DA VINCI SI SYSTEM WITH AN UNKNOWN SERIAL NUMBER. THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NOTHING ABNORMAL FOUND. THE SURGEON REPORTED THAT THE SYNCHROSEAL INSTRUMENT WORKED FINE AND NO ERRORS WERE GENERATED FOR THE INSTRUMENT. THE TARGET ISSUE WAS THE PROSTATE PEDICLE. THE TARGET TISSUE WAS REPORTEDLY UNDER TENSION DURING THE SEALING AND CUTTING PROCESS. THE TARGET TISSUE WAS NOT A VESSEL GREATER THAN 5MM, HAD NO CALCIFICATION, AND NO PREVIOUS RADIATION OR CHEMOTHERAPY. THE SURGEON REPORTED THAT THEY OBSERVED TISSUE EFFECT DURING THE SEALING/SYNCH CYCLE. THE SURGEON SAID THE SYNCHROSEAL INSTRUMENT NEVER CAME INTO CONTACT WITH METAL OBJECTS SUCH AS STAPLES, SUTURES, AND CLIPS DURING THE 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: INTUITIVE SURGICAL INC. (ISI) BECAME AWARE OF A EUROPEAN UROLOGY OPEN SCIENCE ARTICLE TITLED, ¿SALVAGE VERSUS PRIMARY ROBOT-ASSISTED RADICAL PROSTATECTOMY: A PROPENSITY-MATCHED COMPARATIVE EFFECTIVENESS STUDY FROM A HIGH-VOLUME TERTIARY CENTRE¿ (NATHAN, A., FRICKER, M., ET AL., 2021). WITHIN THE CLINICAL JOURNAL ARTICLE, IT WAS CITED -ONE PATIENT SUFFERED FROM RECTAL INJURY WITH INTRAOPERATIVE PRIMARY REPAIR FOLLOWING WHOLE GLAND RADIOTHERAPY. ISI HAS MADE MULTIPLE FOLLOW-UP ATTEMPTS TO THE REACH OUT TO THE AUTHOR TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT. AT THIS TIME, IT WAS UNCONFIRMED AS TO WHETHER A DA VINCI SURGICAL SYSTEM WAS INVOLVED IN THE REPORTED EVENT AND THERE IS NO KNOWN ALLEGATION OF A MALFUNCTION OF A DA VINCI PRODUCT. MOREOVER, THERE IS INSUFFICIENT INFORMATION PROVIDED TO DETERMINE THAT AN INTUITIVE PRODUCT CAUSED OR CONTRIBUTED TO THE OPERATIVE COMPLICATION REFERENCED IN THE ARTICLE.

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 22-NOV-2021, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A INTERNATIONAL JOURNAL OF UROLOGY CASE REPORTS ARTICLE TITLED, ¿ENDOSCOPIC LASER TREATMENT FOR URINE LEAKAGE CAUSED BY AN ISOLATED CALYX AFTER ROBOT-ASSISTED PARTIAL NEPHRECTOMY¿ (INOUE, R., ISOYAMA, N., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, A POST-OPERATIVE COMPLICATION INVOLVING A DA VINCI SURGICAL PROCEDURE WAS NOTED: "AN (B)(6) MAN UNDERWENT ROBOT-ASSISTED PARTIAL NEPHRECTOMY FOR THE TREATMENT OF RENAL CELL CARCINOMA (CT1BN0M0). POSTOPERATIVELY, URINE LEAKAGE WAS OBSERVED AND DID NOT IMPROVE WITH CONSERVATIVE MEASURES. RETROGRADE PYELOGRAPHY AND COMPUTED TOMOGRAPHY REVEALED THAT URINE LEAKAGE ORIGINATED FROM THE ISOLATED CALYX CAUSED BY INFUNDIBULAR STENOSIS. ENDOSCOPIC TREATMENT VIA THE TRANSURETHRAL APPROACH WAS SELECTED TO PRESERVE RENAL FUNCTION. URETEROSCOPY SHOWED THAT THE UPPER CALYX WAS COMPLETELY OBSTRUCTED BY THE SUTURES. THEREFORE, WE CUT THE SUTURE THREAD USING LASER, AND A URETERAL STENT WAS PLACED IN THE UPPER RENAL CALYX. FLUID DRAINAGE IMMEDIATELY DISAPPEARED AFTER THE PROCEDURE, AND THE PATIENT DID NOT LOSE RENAL FUNCTION." ISI HAS REACHED OUT TO THE AUTHOR TO OBTAIN ADDITIONAL INFORMATION BUT

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, PIECES FROM THE CANNULA SEAL BROKE OFF AND FELL INSIDE THE PATIENT'S ABDOMEN. THE SURGEON WAS ABLE TO RETRIEVE ALL FRAGMENTS DURING THE SAME PROCEDURE. THE CANNULA SEAL IS AVAILABLE FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION; HOWEVER, THE FRAGMENTS ARE NOT ABLE TO BE RETURNED. THE CUSTOMER REPLACED THE CANNULA SEAL WITH A BACK-UP ACCESSORY OF THE SAME KIND AND COMPLETED THE PROCEDURE WITH NO REPORTED INJURY. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

Monarch Platform — 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 A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE LOCATION OF THE PNEUMOTHORAX WAS RIGHT LOWER LOBE. A CHEST TUBE WAS PLACED, AND PATIENT WAS HOSPITALIZED FOR OBSERVATION. THE CHEST TUBE WAS REMOVED AND THE PATIENT WAS DISCHARGED.

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 A DA VINCI ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE BLEEDING AND REQUIRED HOSPITALIZATION IN THE ICU. THE SURGEON SAID HE NO LONGER WILL USE THE SYNCHROSEAL INSTRUMENT. INTUITIVE SURGICAL INC. (ISI) CONTACTED THE SURGEON WHO PERFORMED THIS PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE EVENT: THE PROCEDURE OCCURRED IN JUNE BUT THE EXACT DATE WAS NOT PROVIDED. THE PROCEDURE WAS PERFORMED ON A DA VINCI SI SYSTEM WITH AN UNKNOWN SERIAL NUMBER. THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NOTHING ABNORMAL FOUND. THE SURGEON REPORTED THAT THE SYNCHROSEAL INSTRUMENT WORKED FINE AND NO ERRORS WERE GENERATED FOR THE INSTRUMENT. THE TARGET ISSUE WAS THE PROSTATE PEDICLE. THE TARGET TISSUE WAS REPORTEDLY UNDER TENSION DURING THE SEALING AND CUTTING PROCESS. THE TARGET TISSUE WAS NOT A VESSEL GREATER THAN 5MM, HAD NO CALCIFICATION, AND NO PREVIOUS RADIATION OR CHEMOTHERAPY. THE SURGEON REPORTED THAT THEY OBSERVED TISSUE EFFECT DURING THE SEALING/SYNCH CYCLE. THE SURGEON SAID THE SYNCHROSEAL INSTRUMENT NEVER CAME INTO CONTACT WITH METAL OBJECTS SUCH AS STAPLES, SUTURES, AND CLIPS DURING THE PROCEDURE

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A MAKO HIP CASE, MANUAL REAMING WAS ENABLED. THE MEDIAL DISTANCE REMAINING NUMBER SHOWED WE STILL HAD OVER 3MM TO GO, HOWEVER THE SURGEON WENT THROUGH THE MEDIAL WALL. ADDITIONALLY, THE 3D BONE MODEL SHOWED THAT WE WENT THROUGH THE MEDIAL WALL, WHILE THE MEDIAL DISTANCE TO REAM NUMBER WAS STILL OVER 3MM. NO SURGICAL DELAY. CASE TYPE / APPLICATION: LTHA UPDATE 03/JUNE/2021 WG: AS PER MPS RESPONSE, SURGEON ADDRESSED THE ISSUE BY MANUALLY INFERIORIZING THE CUP. SURGICAL DELAY 10 MINUTES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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 REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY SLIPPED OF THE MCS INSTRUMENT AND FELL INTO THE PATIENT. THE MCS TIP COVER ACCESSORY WAS REMOVED FROM THE PATIENT AND WAS REPORTEDLY DISCARDED. THE PROCEDURE WAS COMPLETED USING A BACKUP MCS TIP COVER ACCESSORY WITH NO REPORTED INJURY. THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL TERRITORY ASSOCIATE (CTA) PROVIDED THE FOLLOWING INFORMATION: THE OPERATING ROOM NURSE WHO REPORTED THIS ISSUE TO THE CTA STATED SHE DOES NOT HAVE THE EVENT DATE INFORMATION. THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE. INSTALLATION OF TIP COVER ACCESSORY ON THE MCS INSTRUMENT WAS "EASIER THAN NORMAL." THE MCS TIP COVER ACCESSORY FELL INTO THE ABDOMEN AND THEY RETRIEVED IT WITH THE REMAINING INSTRUMENTS. INSTRUMENT REMOVAL TASK WAS BEING PERFORMED WHEN THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT. THE NURSE TOLD THE CTA THAT THE MCS TIP COVER ACCESSORY AND THE MCS WERE NOT BEEN DAMAGED. THE ORANGE SURFACE WAS NOT VISIBLE AFTER THE MCS TIP COVER ACCESSORY WAS INSTALLED. NO ELECTROLUBE OR OTHER LUBRICANT APPLIED TO THE MCS INSTRUMENT PR

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 HARMONIC ACE WAS SUDDENLY BROKEN. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. A SIMILAR BACKUP DA VINCI INSTRUMENT WAS USED. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT HARM, ADVERSE OUTCOME, OR INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS USED FOR ABOUT ONE HOUR AND THE INSTRUMENT BLADE WAS BROKEN INSIDE THE PATIENT. THE SURGEON REMOVED THE FRAGMENT BY USING A GRASPER, DURING THE SAME PROCEDURE. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE FOUND. DURING A DA VINCI-ASSISTED THYROIDECTOMY SURGICAL PROCEDURE, THE INSTRUMENT BROKE WHILE IT WAS BEING USED FOR DISSECTING TISSUE. ALL THE FRAGMENTS WERE RETRIEVED UPON VISUAL INSPECTION. IT WAS UNKNOWN WHAT CAUSED THE BREAKAGE AS THE INSTRUMENT DID NOT COLLIDE WITH ANY HARD MATERIALS OR OTHER INSTRUMENTS. THERE WAS NO PATIENT INJURY. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE FRAGMENT(S) DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP OR ACCESSORY COLLISION. THE INSTRUMENT WAS NO

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 GASTRIC BYPASS SURGICAL PROCEDURE, A SMALL DISC FELL OFF OF THE SYNCHROSEAL INSTRUMENT AND INTO THE ABDOMEN OF THE PATIENT. THE SMALL DISC WAS REMOVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON (B)(6) 2021 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENT WAS RETRIEVED VIA ROBOTIC INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE AND WAS UNSURE OF THE CAUSE OF THE ISSUE. THE FOLLOWING WAS INFORMATION WAS REQUESTED, BUT WAS UNKNOWN: WHAT SURGICAL TASK WAS BEING PERFORMED AT THE TIME OF THE ISSUE, HOW LONG THE INSTRUMENT HAD BEEN IN USE AT THE TIME OF THE ISSUE, IF THERE WERE ANY COLLISIONS, IF THE INSTRUMENT WAS REMOVED THROUGH THE CANNULA PRIOR TO THE ISSUE, AND IF THERE WAS ANY OTHER DAMAGE TO THE INSTRUMENT OR THE CANNULA ONCE THE INSTRUMENT HAD BEEN REMOVED. THE INSTRUMENT IS AVAILABLE FOR RETURN TO ISI. THERE ARE PHOTOGRAPHIC IMAGES AVAILABLE OF THE INSTRUMENT AND THE FRAGMENT. PATIENT-RE