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 HIATAL HERNIA REPAIR SURGICAL PROCEDURE, PART OF THE BLUE SPRING PAD BROKE OFF OF THE SYNCHROSEAL INSTRUMENT JAW. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE AND WILL BE RETURNED TO ISI FOR ANALYSIS. THE BREAKAGE WAS NOTED DURING DISSECTION OF THE TISSUE NEAR THE CRUS. THE BROKEN FRAGMENT DID FALL INTO THE PATIENT AND WAS RETRIEVED AT THE TIME WITH A LAPAROSCOPIC NEEDLE DRIVER INSTRUMENT. THE SURGEON IS UNSURE AS TO WHAT CAUSED THE BREAKAGE. THE BREAKAGE WAS OBSERVED 15 MINUTES INTO USING THE SYNCHROSEAL INSTRUMENT. THE ADDITIONAL INSTRUMENT USED AT THE TIME OF THE PROCEDURE WAS A FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THE SYNCHROSEAL INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS DURING THE PROCEDURE, AND THE WRIST WAS STRAIGHTENED PRIOR TO REMOVAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY WITH NO ADVERSE PATIENT CONSEQUENCES.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2020, THE SURGEON NOTIFIED THE CLINICAL REPRESENTATIVE (CR) WHO ASSISTED THE SURGERY, THAT DURING THE POST OP SCAN AND MERGE THERE WAS DEVIATION FROM THE PLANNED ENTRY BY ~5MM. THE SURGEON SAID THERE WAS NO IMPACT TO THE PATIENT, BUT THE READING ON THE RNS DEPTH LEADS WILL BE AFFECTED AS THEY ARE NOT IN THE PLANNED LOCATION. THE PATIENT WAS REGISTERED USING CONTACTLESS REGISTRATION. THE PATIENT WAS WEARING A FACE MASK DURING THE CT SCAN, SO THE METAL BRIDGE OF THE FACE MASK AS WELL AS THE ELASTIC LOOPS OF THE MASK WERE PROMINENT IN THE SCAN. THE VERIFICATION PROCESS LOOKED TO BE WITHIN ACCEPTABLE RANGE AND NO NOTICEABLE SHIFTS IN THE HEAD OCCURRED TO THE CR¿S AND SURGEON¿S KNOWLEDGE.

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 21-JUL- 2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A SURGICAL ENDOSCOPY ARTICLE TITLED, ¿ROBOTIC TREATMENT FOR URINARY TRACT ENDOMETRIOSIS: PRELIMINARY RESULTS AND SURGICAL DETAILS IN A HIGH-VOLUME SINGLE-INSTITUTIONAL COHORT STUDY¿ (DIMAIDA, F., MARI,. A., MORESELLI, S., ET AL., 2020). THE AIM OF THE STUDY WAS TO PRESENT THE SURGICAL TECHNIQUES AND THE POSTOPERATIVE OUTCOMES IN WOMEN TREATED WITH ROBOTIC EXCISION FOR DEEP ENDOMETRIOSIS INVOLVING THE URINARY TRACT. THIS STUDY RETROSPECTIVELY REVIEWED THE PROSPECTIVELY RECORDED CLINICAL DATA OF WOMEN CONSECUTIVELY UNDERGOING MINIMALLY INVASIVE TREATMENT FOR COMPLEX ENDOMETRIOSIS INVOLVING URINARY TRACT IN OUR CENTER BETWEEN JANUARY 2012 AND JUNE 2018. A TOTAL OF 74 CONSECUTIVE PATIENTS WERE ENROLLED AND, OF WHICH, 46 WERE TREATED WITH ROBOTIC SURGERY WITH EITHER A DA VINCI SI OR XI DA VINCI SURGICAL SYSTEM. ALL THE PATIENTS RECEIVED A PREOPERATIVE MULTIDISCIPLINARY EVALUATION WITH THE GENERAL SURGEON, THE GYNECOLOGIST, AND THE UROLOGIST DUE TO THE FREQUENT CONCOMITANT INVOLVEMENT OF BOWEL AND GENITAL SYSTEM. PATIENTS UNDERGOING ROBOTIC SURGERY WERE TREATED WITH THE SI OR XI DA VINCI SURGICAL SYSTEM. WITHIN THE JOURNAL A

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, THE TIP OF THE HARMONIC ACE CURVED SHEARS BROKE AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED AND A BACKUP INSTRUMENT OF THE SAME KIND WAS INSTALLED TO PROCEED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE OPERATING ROOM (OR) NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: ALL FRAGMENTS WERE RETRIEVED DURING THE SAME SURGICAL PROCEDURE. REPORTEDLY, THE TIP WAS NEATLY BROKEN AND IMMEDIATELY REMOVED FROM THE PATIENT'S BODY. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE SURGEON WAS DISSECTING TISSUE WHEN THE DEVICE FRAGMENT FELL INSIDE THE PATIENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE AND THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS. THE INSTRUMENT WAS NEVER REMOVED PRIOR TO THE BREAKAGE. UPON THE FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED AND THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE TO THE C

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.

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 PLACED AT L5 WAS NOT PLACED ACCORDING TO THE SURGICAL PLAN. THE MISPLACED SCREW WAS REMOVED.

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.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER CASE SURGEON SENT ME A POST OP X-RAY THAT SHOWED A ANTERIOR FEMORAL NOTCH. NO SURGICAL DELAY. CASE TYPE: TKA.

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 THE RIGHT L4 SCREW WAS NOT PLACED ACCORDING TO PLAN. THE SCREW WAS REMOVED AND REPLACED IN THE PROPER POSITION.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON THE MORNING OF (B)(6) 2020, THE SURGEON WAS USING ROSA TO IMPLANT A RNS DEVICE. DURING THE FIRST ATTEMPT OF REGISTRATION THE ROBOT HAD A 'UNRECOVERABLE ERROR' AND SHUTDOWN. THIS WAS AFTER THE INITIAL REGISTRATION POINTS WERE PLACED AND TWO OF THE POINTS HAD BEEN ADJUSTED FOR ACCURACY. THE ARM MOVED TO THE INTERMEDIATE POSITION AND THEN WAS ABOUT TO START THE AUTOMATIC SCAN OF THE PATIENT'S FOREHEAD WHEN IT SHUTDOWN. THE ROBOT WAS REBOOTED AND THE REGISTRATION PROCESS WAS STARTED AGAIN. DURING THE MATCHING OF THE INITIAL REGISTRATION POINTS, THE ROBOTIC ARM BEGAN TO MAKE A GRINDING NOISE AT THE 2ND JOINT FROM THE BASE. THIS SOUND WAS NOT A HUMMING NOISE, BUT A MECHANICAL GRINDING NOISE. THE ARM WAS IN POSITION TO COLLECT THE DATA POINT FROM THE LEFT LATERAL CANTHUS AND THE ARM WAS NOT BEING MOVED WITH EXCESSIVE FORCE. THE MOVEMENT OF THE ARM COULD BE DESCRIBED AS NORMAL. THE SURGEON NOTICED THE SOUND/FEEDBACK FROM THE ARM AND ALERTED THE COMPANY FIELD SERVICE ENGINEER. ROUGHLY, 5 SECONDS PASSED AND THE ROBOT HAD THE SAME ERROR IT HAD BEFORE. RESTARTED THE ROBOT AND TRIED TO CONNECT TO THE CONTROLLER AND CONTINUE WITH THE SURGERY, BUT THE ROBOT WOULD NOT CONNECT. THE USE OF ROSA F

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.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING SECOND ATTEMPT AT REGISTRATION, ROSA WAS PERFORMING AUTOMATIC SCANNING PORTION OF CONTACTLESS REGISTRATION. ARM DISCONNECTED, AND SHUTDOWN ERROR OCCURRED. ROBOT WAS SHUTDOWN AND THEN RESTARTED. ROBOT WAS UNABLE TO RECONNECT TO ARM, SO SHUTDOWN OCCURRED AGAIN. THE FIELD SERVICE ENGINEER (FSE) ATTEMPTED SEVERAL SHUTDOWNS, WITHOUT SUCCESS. ROBOT WAS REMOVED FROM PATIENT, AND MANUAL RELEASE WAS ATTEMPTED OUTSIDE OF OR. ARM WAS STILL UNABLE TO CONNECT. THE FSE CONTINUED TO PERFORM MANUAL RELEASE AND CONNECTION, BUT WITHOUT SUCCESS. ROSA USE DURING THE SURGERY WAS ABORTED, AND PROCEEDED WITH BRAINLAB INSTEAD. DELAY OF PROCEDURE NEARLY AN HOUR. ABLATION 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: 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.

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 CALLED A FIELD SERVICE ENGINEER (FSE) AND TOLD, THAT THE ROBOT IS STUCK IN A SINGULAR POSITION FREE IN SPACE. ROSA LETTER BOTTOM UP. ROSANNA ASKED TO RESTART, THE SURGEON DID SO. AFTER THE RESTART THE SYSTEM STARTED THE CLEARANCE PROCEDURE, BUT BEFORE THEY COULD MOVE THE ARM THE SYSTEM SHUT DOWN AGAIN. THE FSE ASKED THEM TO SHUT DOWN AND WAIT POWERED OFF MINIMUM 1 MINUTE, BUT THIS ALSO DIDN´T HELP. THEY TRIED SEVERAL TIMES. FINALLY THEY USED KINEVERIF TO MOVE THE ARM TO HOME POSITION AND WERE ABLE TO PROCEED WITH SURGERY. AFTER 4 SEEG-ELECTRODES THE SURGEON MOVED THE ARM DOWN USING THE AXIAL COOPERATIVE MODE. THE ARM TOUCHED SLIGHTLY THE MAYFIELD WITH AXIS 5. THE SURGEON WANTED TO PUSH THE ARM BACK, BUT IT GOT STUCK AGAIN. SYSTEM SHUT DOWN. CLEARANCE PROCEDURE NOT WORKING AFTER RESTART. THEY REMOVED THE PATIENT FROM THE ROBOT, BUT EVEN THEN THE ROBOT DID NOT MOVE. THEY AGAIN USED KINEVERIF TO MOVE THE ROBOT TO HOME POSITION. AFTER NEW INSTALLATION OF THE PATIENT AND REREGISTERING, THEY FINISHED THE SURGERY.

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 FIVE PEDLCLE SCREWS WERE NOT PLACED ACCORDING TO THE SCREW PLAN AT THE LEFT T8-T12 LEVELS. ALL PEAICIE SCREWS FROM T8-T12 AND THE RIGHT SIDE SCREW AT T12 WERE REMOVED AND REPLACED USING TRADITIONAL MIS TECHNIQUE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PATIENT FOLDER LOADED IN ON ACCIDENTAL OVERWRITE FROM USB DRIVE RATHER THAN FROM ROSA MEMORY. THIS CAUSED CHANGES TO THE ORIGINAL PLANNING TO BE DELETED AND CAUSE THE SURGEON TO HAVE TO RE-MAKE THE CHANGES MADE PRIOR TO THE BEGINNING OF SURGERY - DONE ON ROSA. ATTEMPTED TO FIND ARCHIVED FILES IN THE MAINTENANCE SIDE, BUT NO FILES REMAINED FROM THE OVERWRITTEN PLAN. PATIENT WAS ALREADY UNDER ANESTHESIA AND CAUSED A 45 MINUTE DELAY IN THE SURGERY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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: ROBOTIC CLIP APPLIER NOT HOLDING CLIPS. FDA SAFETY REPORT ID # (B)(4).

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING RNS PROCEDURE, CT WAS OBTAINED AFTER PATIENT WAS UNDER ANESTHESIA, NO INCISION. CT WAS UNABLE TO MERGE PROPERLY TO MP2RAGE IMAGE SERIES. BOTH AUTOMATIC AND SEMIAUTOMATIC FUSION WAS ATTEMPTED WITHOUT SUCCESS. SOFTWARE FROZEN WHILE ATTEMPTING TO ACCESS 'SEMI-AUTOMATIC' FUSION. ROSA SHUTDOWN AND RESTARTED TWICE. CT WAS DETERMINED TO HAVE ARTIFACT; SURGEON CHOSE TO GET ANOTHER CT SCAN TO SEE IF WOULD MERGE MORE SUCCESSFULLY. SECOND CT SCAN OBTAINED WHILE PATIENT UNDER ANESTHESIA AS WELL. CHALLENGE STILL WHILE ATTEMPTING TO MERGE TO MP2RAGE, AND T1 POST MRI. DELAY 1 HOUR, PATIENT UNDER ANESTHESIA, NO INCISION MADE. FOLLOWING SURGEON CONFIRMATION OF PROPER MERGE, SURGERY PROCEEDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IN REGARD TO THE ARTICLE ¿EARLY FEASIBILITY SURVEILLANCE OF GYNECOLOGIC ROBOTIC-ASSISTED SURGERIES IN JAPAN¿ WRITTEN BY TSUKASA BABA, MASAKI MANDAI, HIROTAKA NISHI, OSAMU NISHII, JO KITAWAKI, MORIO SAWADA, KEIICHI ISAKA AND TOMOYUKI FUJII, AND PUBLISHED IN THE JOURNAL OF OBSTETRICS AND GYNAECOLOGY RESEARCH, DR. TSUKASA BABA INDICATED THAT HE HEARD OF A COLLISION INDUCED RECTAL INJURY THAT OCCURRED ¿OUTSIDE OF VIEW.¿ DR. BABA INDICATED THAT HE WAS ¿NOT SURE [IF] THE PATIENT SUFFERED FROM SEPTIC SHOCK OR UNDERWENT ANASTOMOSE OR OTHER INTENSIVE CARE.¿ INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT, BUT AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN 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: IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY PROCEDURE, THE SURGEON HAD GRASPED UNSPECIFIED TISSUE WITH A HARMONIC ACE INSTRUMENT AND WAS NOT AWARE THAT THE INSTRUMENT HAD A BROKEN METAL PIECE. IT WAS ALSO NOTED THAT THERE WAS "EXCESSIVE BLEEDING" AND THE SURGICAL STAFF HAD DIFFICULTY CONTROLLING THE BLEEDING. ACCORDING TO THE INITIAL REPORTER, THE SURGEON BELIEVES THE INSTRUMENT CAUSED OR CONTRIBUTED TO THE BLEEDING. ACCORDING TO THE INITIAL REPORTER, NO MEDICAL INTERVENTION WAS ADMINISTERED DUE TO THE BLEEDING AND THE SURGICAL PROCEDURE WAS COMPLETED ROBOTICALLY. PER THE INITIAL REPORTER, THE PATIENT'S CURRENT STATUS WAS "RECOVERED." ON 10-AUG-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SURGICAL PROCEDURE WAS NOT RECORDED ON VIDEO. THE CUSTOMER COULD NOT RECALL WHAT SPECIFIC TISSUE WAS INVOLVED WITH THE "EXCESSIVE BLEEDING." AFTER A TISSUE INCISION WAS MADE USING THE HARMONIC ACE INSTRUMENT, THE SURGEON ATTEMPTED TO USE THE COAGULATION FUNCTION. AT THAT TIME, THE CUSTOMER CLAIMED THAT THE INSTRUMENT DID NOT WORK AND BLEEDING OCCURRED. THE SURGEON WAS ABLE TO ACHIEVE HEMOSTASIS BY U

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 TO TREAT DEGENERATIVE DISC USING FIXATION. IT WAS REPORTED THAT A JOINT 6 SHIFT OCCURRED DURING THE PROCEDURE. THE JOINT BROKE WHILE ON THE THIRD OUT OF FOUR TRAJECTORIES. THE TOOLS WERE ALREADY IN POSITION AND THE HOLE HAD BEEN DRILLED WHEN IT BROKE SO THE SURGEON RESUMED WITH THE WIRE. THE MANUFACTURER REPRESENTATIVE TRIED DOING A FULL SHUTDOWN OF THE SYSTEM 2-3 TIMES TO SEE IF THE ERROR WOULD DISAPPEAR, BUT THE ISSUE WAS NOT RESOLVED. THE SURGICAL ARM COULD NOT BE SENT TO THE RIGHT L5 TRAJECTORY. THE CASE WAS ABORTED DUE TO THE SHIFT AND THE FOURTH SCREW WAS PLACED FREEHAND. THE REPRESENTATIVE LATER REPORTED THAT THE THIRD SCREW WAS DETERMINED TO BE MISPLACED BY LESS THAN 3.5 MM. THE PATIENT HAD NEW RIGHT LEG PAIN AFTER THE SURGERY SO A CT WAS DONE AND THAT WAS WHEN THE SCREW WAS DETERMINED TO BE MEDIAL. A REVISION PROCEDURE USING THE GUIDANCE SYSTEM WAS DONE ON (B)(6) 2020 TO REPOSITION THE SCREW. THE SCREW WAS ACCURATELY PLACED DURING THE REVISION. THE INITIAL PROCEDURE WAS DELAYED LESS THAN AN HOUR.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS REPORTED: "PT PRESENTED TO EMERGENCY DEPARTMENT W/ COMPLAINT OF PAIN AND SWELLING TO RIGHT LOWER EXTREMITY. XRAY SHOWED PERIHARDWARE FRACTURE AND PT ADMITTED. PT PLACED IN KNEE IMMOBILIZER ON (B)(6) 2020 AND DISCHARGED TO INPATIENT REHAB."

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, IT WAS NOT POSSIBLE TO ACTIVATE FIREFLY. THE TECHNICAL SUPPORT ENGINEER (TSE) HAD THE SURGEON CHECKED THE USER SETTINGS AND RESTORED THEM TO DEFAULT. THE TSE REVIEWED THE LOGS AND DETECTED ERROR 48275 AND 48205. THE TSE INSTRUCTED THE CUSTOMER TO SWAP THE ENDOSCOPE AND PERFORM A SYSTEM REBOOT WITH A HARD CYCLE, WITHOUT SUCCESS. THE CUSTOMER SWAPPED THE VISION SIDE CART (VSC) TO COMPLETE THE SURGERY. THE PROCEDURE WAS CONVERTED TO ANOTHER DV WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE CAUSED A DELAY OF APPROXIMATELY 1.5 HOURS. THE ENDOSCOPE WILL NOT BE RETURNED TO INTUITIVE AS THE ENDOSCOPE CONTROLLER (EC) CAUSED THE ISSUE. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS REPORTED TO BE DOING FINE. THE CUSTOMER DID NOT HAVE ANY OTHER VISION ISSUES PRIOR TO FIREFLY NOT WORKING.

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 TO TREAT DEGENERATIVE DISC WITH FIXATION. IT WAS REPORTED THAT DURING A L4-S1 REVISION CASE, THE RIGHT L5 SCREW DEVIATED FROM THE PLANNED TRAJECTORY. THE SCREW WAS DEVIATED APPROXIMATELY TWO MM INFERIOR. THE MANUFACTURER REPRESENTATIVE THOUGHT SURGICAL TECHNIQUE OF WORKING ON THE OPPOSITE SIDE OF SCREW PLACEMENT CAUSED THE DEVIATION. THE PATIENT DID EXPERIENCE SOME DISCOMFORT AND THEY HAD DEVELOPED A CYST IN THE SAME AREA OF THE SCREW AFTER THE SURGERY. THE SCREWS WERE REPOSITIONED ON (B)(6)2020 USING NAVIGATION TO ASSIST WITH THE DISCOMFORT. THE SURGEON INDICATED THAT IT WAS UNKNOWN WHETHER IT WAS THE SCREW, CYST OR BOTH THAT CAUSED THE PROBLEM. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN AN 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: 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: 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 SURGICAL PROCEDURE, A SPLIT WAS EXTENDING INTO THE DARKER GRAY PLASTIC ON THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE DA VINCI COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE MCS INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE IN USE APPROXIMATELY FOUR HOURS INTERMITTENTLY, AND THEN A TEAR ON THE WAS NOTED ON THE MCS TIP COVER ACCESSORY. WHILE THE MCS INSTRUMENT WAS BEING REMOVED FROM THE PATIENT, THE MCS TIP COVER ACCESSORY FELL INSIDE OF THE PATIENT HAVING POSSIBLY GOTTEN CAUGHT ON THE CANNULA. THE MCS TIP COVER ACCESSORY WAS RETRIEVED WITH A LAPAROSCOPIC INSTRUMENT. THERE WAS NO MCS INSTRUMENT FUNCTIONALITY ISSUE NOTED. IT IS UNKNOWN IF THE MCS INSTRUMENT COLLIDED WITH ANY OTHER INSTRUMENTS, IF THE SURGICAL STAFF FELT ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA, OR IF THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL. THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE TO THE MCS

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 INTRA-OPERATIVELY OF A SPINAL PROCEDURE TO TREAT DEGENERATIVE DISC WITH FIXATION. IT WAS REPORTED THAT A DAY AFTER THE SURGERY THEY DISCOVERED THAT THE L4 LEFT WAS MEDIAL TO PLAN. THE SUSPECTED CAUSE OF THE DEVIATION WAS SOFT TISSUE PRESSURE. A REVISION WAS DONE TO CORRECT THE SCREW. IT WAS UNKNOWN HOW MUCH THE SCREW WAS DEVIATED. THE MANUFACTURER REPRESENTATIVE HAD COMPLETED A 10 POINT ACCURACY CHECK TWICE AND THE SHOULDER CALIBRATION WAS IN SPECIFICATION AFTER THE PROCEDURE. THE GUIDANCE SYSTEM WAS USED IN TWO CASES WITHOUT ANY FURTHER ISSUE. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS NOT DELAYED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE COMPANY FIELD SERVICE ENGINEER (FSE) ASSISTED THE SURGEON FOR A BRAIN SURGERY. THE FIRST LASER REGISTRATION ATTEMPT WAS STARTED AROUND 8:20AM EST, AND THERE WAS AN ERROR MESSAGE GIVEN AFTER PERFORMING ALL THE STEPS. ON THE 3D SEGMENTATION, IT WAS NOTICEABLE THAT THE RED POINT FOR THE TOP OF THE FOREHEAD AND THE BLUE MARKS FOR THE AUTOMATIC SCAN AT THE TOP OF THE FOREHEAD WERE WELL UNDER THE SKIN. ALL THE OTHER RED POINTS LOOKED GOOD, AND THE BLUE MARKS FOR THE AUTOMATIC AND MANUAL SCANS LOOKED GOOD AS WELL EVERYWHERE ELSE, BUT WAS OFF AT THE TOP OF THE FOREHEAD. WHEN LOOKING AT THE VERIFICATION, ALL POINTS WERE WITHIN THE RED CIRCLE EXCEPT AT THE TOP OF THE FOREHEAD, WHERE IT APPEARED TO BE SHOWING THE LASER AT THE BONE OF THE SKULL INSTEAD OF THE SKIN. THE LASER REGISTRATION WAS ATTEMPTED AGAIN USING THE CT SCAN, BUT THE EXACT SAME RESULT SHOWED, WHERE THE BLUE ZIG ZAG LINES OF THE AUTOMATIC SCAN AT THE TOP OF THE FOREHEAD APPEARED TO BE CUT OFF ON THE 3D SEGMENTATION, AND THE RED POINT AT THE TOP OF THE FOREHEAD WAS ALSO NOT VISIBLE BECAUSE IT WAS UNDER THE SKIN. THE MRI WAS THEN ATTEMPTED TO BE USED AS THE 3D SEGMENTATION FOR LASER REGISTRATION, BUT THE SAME RESULT OCCURRED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AT ROUGHLY 13:05, SURGEON WAS CLEARING ROBOT ARM FROM IMPLANTATION OF DEPTH ELECTRODE, WHEN 'FREE AND FAST' WERE SELECTED ON SCREEN, A SMALL COLLISION OCCURRED BECAUSE THE DRILL ADAPTOR WAS NOT ENTIRELY CLEAR FROM THE DIXI BOLT. SURGEON ATTEMPTED TO CLEAR, BUT A COLLISION AND SHUTDOWN OCCURRED. THE COMPANY FIELD SERVICE ENGINEER INSTRUCTED SURGEON TO SHUTDOWN ROSA ENTIRELY, AND WAIT TO CONNECT TO SOFTWARE. UPON RESTART, COLLISION WAS STILL DETECTED. SURGEON RESTARTED ROSA SYSTEM A SECOND TIME, AND WAS ABLE TO CLEAR ARM. TO PROCEED, SURGEON DROVE BACK TO TRAJECTORY AND CONFIRMED THAT NO SHIFT HAD OCCURRED. CASE PROCEEDED AS PLANNED. DELAY 15 MINUTES, SEEG, PATIENT UNDER ANESTHESIA.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON MAY 11, 2020 THE SURGEON SENT THE DATABASE ABOUT THE ONGOING PMCF FOR THE ROSA ONE DEVICE TO A ZIMMER BIOMET TEAM MEMBER. THIS TEAM MEMBER TRANSMITTED THE SERIOUS INJURY EVENTS IDENTIFIED IN THIS DATABASE TO THE COMPLAINT HANDLING TEAM ON (B)(6) 2020. PATIENT ID: NOT PROVIDED. SURGERY DATE: NOT PROVIDED. TYPE OF EVENT: ADVERSE EVENT (AE). SEVERITY: MILD. RELATION TO DEVICE: DEFINITELY. RELATION TO INSTRUMENT: DEFINITELY. RELATION TO PROCEDURE: NOT RELATED. DESCRIPTION: SKIVING OF THE L5 G SCREW (NOT ADAPTED ANCILLARY EQUIPMENT: PATHFINDER). REQUIRED TO REPOSITION THE SCREW PER OPERATIVELY. THE EFFECT WAS EXACERBATED BY THE ANCILLARY EQUIPMENT WHICH WASN'T GRIPPING WELL ENOUGH (NO AUTO TAP, REQUIRED A STRONG PRESSURE ON THE SPINE). SCREW REPOSITIONED WITHOUT ISSUE, BUT WITH GRADE C ACCURACY (ACCORDING TO THE GERTZBEIN AND ROBBINS CLASSIFICATION SYSTEM). REQUIRED THAT THE SECOND SCREW PLACED HAD A LARGER DIAMETER.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CONTACTLESS REGISTRATION PERFORMED SUCCESSFULLY; DURING VERIFICATION STEP SURGEON MOVED LASER TO VERIFY SKIN MATCHING. SURGEON PUSHED "RECORD" , AND SOFTWARE DID NOT RESPOND CORRECTLY. SOFTWARE ONLY ZOOMED IN FOR ONE OF THE VIEWS AND IT WAS ZOOMED IN TOO FAR TO CORRECTLY VIEW AN VERIFY. SEVERAL ATTEMPTS WERE MADE, BUT SOFTWARE WAS NOT ZOOMING IN CORRECTLY. SURGEON ATTEMPTED TO MANUALLY ZOOM IN ALL VIEWS, BUT FOUND IT CHALLENGING. THE COMPANY FIELD SERVICE ENGINEER (FSE) SUGGESTED SURGEON SHUTDOWN AND RESTART SOFTWARE. DELAY OF PROCEDURE ROUGHLY 25 MINUTES. PATIENT UNDER ANESTHESIA, NO INCISION MADE, CASE PROCEEDED NORMALLY FOLLOWING RESTART. SEEG SURGERY, FSE PROVIDED REMOTE/ VIDEO SUPPORT.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6), 2020 THE SURGEON SENT THE DATABASE ABOUT THE ONGOING PMCF FOR THE ROSA ONE DEVICE TO A ZIMMER BIOMET TEAM MEMBER. THIS TEAM MEMBER TRANSMITTED THE SERIOUS INJURY EVENTS IDENTIFIED IN THIS DATABASE TO THE COMPLAINT HANDLING TEAM ON (B)(6), 2020. PATIENT ID: NOT PROVIDED. SURGERY DATE: NOT PROVIDED. TYPE OF EVENT: SERIOUS ADVERSE EVENT (SAE). SEVERITY: SEVERE. RELATION TO DEVICE: DEFINITELY. RELATION TO INSTRUMENT: NOT RELATED. RELATION TO PROCEDURE: NOT RELATED. DESCRIPTION: REDUCTOR AND CANULA BLOCKED. THIS LEAD TO AN ABNORMAL PATIENT SHIFT. NOT SEEN INITIALLY. REQUIRED TO REPLACE THE K WIRES (PATIENT MOBILISATION THAT LEAD TO A K WIRES POSITIONING ERROR. REQUIRED REPOSITIONING IN PER OP.). A NEW REGISTRATION WAS PERFORMED AND THE K WIRES WERE REPOSITIONED WITH THE HELP OF THE ROBOT. THE PATIENT HAD TO BENEFICIATE TWO TIMES OF A REGISTRATION DUE TO THE CANULA BEING BLOCKED DURING THE DRILLING (TWO TIMES DURING THE SURGERY) THAT LEAD TWO TIMES TO AN ABNORMAL PATIENT SHIFT. THE FIRST TIME THE SURGERY WAS CONTINUED BUT WHEN THE SURGEON FACED A 'NON BONE' FEELING A CONTROL WAS PERFORMED WHICH INDICATED THE INCORRECT K WIRES POSITION, THEREFORE A NEW REGISTRATION WAS PERFORME

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 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) HAS ATTEMPTED TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.

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.

Mazor Renaissance — 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 THERE WERE DEVIATIONS DURING THE PROCEDURE. THE FIRST AND THIRD SCREWS PLACED WERE TOO LATERAL. THE CAUSE OF THE DEVIATION AND THE AMOUNT OF DEVIATION WAS UNKNOWN. THE SECOND AND FOURTH SCREWS PLACED WERE ACCURATE. THE DEVIATIONS WERE RECOGNIZED IN THE POST-OP CT SCAN. A REVISION WAS DONE ON THE SAME DAY TO MANUALLY REPLACE THE SCREWS. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED MORE THAN AN HOUR.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A FIELD SERVICE ENGINEER (FES) SUPPORTED AN SEEG CASE AT SPECTRUM HEALTH FOR DR. (B)(6) ON (B)(6) 2020 USING DEVICE S/N (B)(4). THE ORIGINAL CT SCAN THAT HAD BEEN TAKEN FOR SURGERY WAS DETERMINED TO BE UNUSABLE SINCE THE PATIENT HAD A MASK ON DURING THE SCAN. THE MASK COULD HAVE MADE THE LASER REGISTRATION INACCURATE, SO THE SURGEON DECIDED TO GET ANOTHER CT SCAN THAT MORNING BEFORE THE CASE. THE NEW CT IMAGING WAS PLACED ON A USB, AND IT WAS ATTEMPTED TO BE UPLOADED THROUGH THE ROSA SOFTWARE GOING THROUGH THE 'USB' PATHWAY. WHEN THE IMAGING WAS SELECTED, THE RESOLUTION APPEARED TO BE 0X0. THE FSE ATTEMPTED TO LOOK AT THE DICOM HEADINGS TO SEE IF THERE WAS ANYTHING THAT STOOD OUT, BUT NOTHING APPEARED TO BE AN ISSUE. THE FSE ATTEMPTED TO CONTACT RADIOLOGY AT THE HOSPITAL, BUT WAS UNABLE TO GET THE SUPPORT NEEDED. AFTER ABOUT A 45 MINUTE DELAY, THE FSE THEN ATTEMPTED TO GO THROUGH IQ-VIEW AND SELECT THE IMAGING GOING THROUGH THAT DIFFERENT PATHWAY. WHEN THE IMAGING WAS SELECTED AND UPLOADED THROUGH IQ-VIEW, THE CT IMAGING APPEARED ON THE ROSA SOFTWARE AND THE RESOLUTION WAS NO LONGER 0X0 AND COULD CORRECTLY BE UPLOADED AND MERGED. THERE WERE NO OTHER ISSUES EXPERIENCED AFTER THAT PO

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 BARIATRIC REVISION SURGICAL PROCEDURE, THE PATIENT DEVELOPED A HEMATOMA NEAR THE AREA OF DISSECTION WITH A SYNCHROSEAL INSTRUMENT. INITIAL INFORMATION RECEIVED FROM THE REPORTER INDICATED THAT HE BELIEVED THIS WAS CAUSED BY THE SYNCHRO SEAL INSTRUMENT THAT WAS USED DURING A BARIATRIC ROBOTIC PROCEDURE. THE PATIENT REPORTEDLY HAD A SECOND (UNSPECIFIED) PROCEDURE TO ADDRESS THE HEMATOMA. IT WAS NOTED THAT THE INSTRUMENT WAS DISCARDED AS NO ISSUE WAS SUSPECTED FOLLOWING INITIAL PROCEDURE COMPLETION. ON (B)(6) 2020, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT AFTER UNDERGOING A SLEEVE GASTRECTOMY PROCEDURE ON AN UNSPECIFIED DATE, THE PATIENT WAS DISCHARGED WITH NO ISSUE REPORTED. HOWEVER, POST-OPERATIVELY THE PATIENT HAD NOT BEEN ¿FEELING WELL¿ AND CALLED THE SURGEON TO REPORT IT. THE SURGEON RECOMMENDED THAT THE PATIENT COME INTO THE HOSPITAL. HOWEVER, THE PATIENT DECIDED TO GO TO ANOTHER HOSPITAL TO SEEK TREATMENT. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A DIAGNOSTIC TEST CONDUCTED, WHICH INDICATED A POSSIBLE HEMATOMA. IT IS BELIEVED THAT THE PATIENT UNDE

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.

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 TWO PEDICLE SCREWS WERE NOT PLACED ACCORDING TO THE SCREW PLAN AT LEFT L3 AND RIGHT L4. INTRA-OPERATIVE IMAGING SHOWED THAT THE L3 SCREW WAS PLACED SUPERIOR IN THE DISC SPACE, AND THE L4 SCREW WAS LATERAL OF THE VERTEBRAL BODY. THE SCREWS WERE REMOVED AND PLACED USING NAVIGATED INSTRUMENTS BUT WITHOUT USE OF THE ROBOTIC ARM.

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 TWO PEDICLE SCREWS WERE NOT PLACED ACCORDING TO THE SCREW PLAN AT THE LS LEVEL. INTRA-OPERATIVE IMAGING SHOWED THAT THE SCREWS WERE PLACED THROUGH THE SUPERIOR ENDPLATES AND BORDERS OF THE PEDICLES. THE SCREWS WERE REMOVED AND PLACED WITHOUT USE OF THE SYSTEM.