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, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY LOOSENED DURING USE. IT WAS ALLEGED THAT THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT AND WAS NOT RETRIEVED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF DATE OF THIS REPORT.

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.

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 — 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 MYOMECTOMY SURGICAL PROCEDURE, THE CUSTOMER WAS USING TWO SP NEEDLE DRIVERS FOR SUTURING. THE CUSTOMER FOUND DAMAGE ON THE INSTRUMENT SHEATHS AND CAMERA SHEATH. FRAGMENTS FROM AN UNKNOWN SOURCE WERE IDENTIFIED AND RETRIEVED FROM THE PATIENT DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE OR NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE. THERE WERE NO POST-OPERATIVE TESTS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. BOTH THE CAMERA SHEATH AND INSTRUMENT SHEATH WERE IN USE FOR 30-40 MINUTES PRIOR TO THE ISSUE AND WERE INSPECTED PRIOR TO USE. THE CUSTOMER CONFIRMED THAT THE INSTRUMENT SHEATH WAS FOUND TO BE SCRATCHED AFTER THE SURGERY. THE SURGEON DID NOT NOTICE ANY ISSUES WITH FUNCTIONALITY DURING THE SURGICAL PROCEDURE. THE CUSTOMER DID NOT HEAR ANY SOUND OF INSTRUMENTS COLLIDING WITH ANOTHER DEVICE OR OTHER HARD MATERIAL, BUT HEARD A "RELATED ERROR NOTIFICATION." THE FRAGMENTS DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP/ACCESSORY COLLISION. THE INSTRUMENT WAS NOT REMOVED INTR

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 MYOMECTOMY SURGICAL PROCEDURE, THE CUSTOMER FOUND DAMAGE ON THE INSTRUMENT SHEATH AND CAMERA SHEATH. FRAGMENTS FROM AN UNKNOWN SOURCE WERE IDENTIFIED AND RETRIEVED FROM THE PATIENT DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE OR NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE. THERE WERE NO POST-OPERATIVE TESTS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. BOTH THE CAMERA SHEATH AND INSTRUMENT SHEATH WERE IN USE FOR 30-40 MINUTES PRIOR TO THE ISSUE AND WERE INSPECTED PRIOR TO USE. THE CUSTOMER CONFIRMED THAT BOTH SHEATHS WERE FOUND TO BE SCRATCHED AFTER THE SURGERY. THE SURGEON DID NOT NOTICE ANY ISSUES WITH FUNCTIONALITY DURING THE SURGICAL PROCEDURE. THE CUSTOMER DID NOT HEAR ANY SOUND OF INSTRUMENTS COLLIDING WITH ANOTHER DEVICE OR OTHER HARD MATERIAL, BUT HEARD A "RELATED ERROR NOTIFICATION." THE FRAGMENTS DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP/ACCESSORY COLLISION. THE INSTRUMENT WAS NOT REMOVED INTRAOPERATIVELY. THE WRIST WAS STRAIGHTENED UPON THE FINAL REMOVAL OF T

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.

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)(4) 2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A WORLD JOURNAL OF SURGERY ARTICLE TITLED, ¿MINIMALLY INVASIVE VERSUS OPEN PANCREATIC SURGERY IN PATIENTS WITH MULTIPLE ENDOCRINE NEOPLASIA TYPE 1¿ ( C. LOPEZ, ET AL. 2016). PER THE CLINICAL ARTICLE, EIGHT HOURS AFTER UNDERGOING A DA VINCI-ASSISTED SPLEEN-PRESERVING DISTAL PANCREATIC RESECTION PROCEDURE, THE PATIENT EXPERIENCED "LIFE-THREATENING" POST-OPERATIVE BLOOD LOSS. THE PATIENT UNDERWENT RESUSCITATION AND AN EMERGENCY LAPAROTOMY TO CONTROL BLEEDING FROM THE SPLENIC ARTERY. THE BLEEDING WAS "MOST LIKELY CAUSED BY A NECROSIS OF THE VESSEL WALL RESULTING FROM THE ULTRACISION DEVICE."

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 LIVER RESECTION PROCEDURE, WHILE USING THE HARMONIC ACE INSTRUMENT THE JAW BROKE OFF AND FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED AND REMOVED FROM THE PATIENT DURING THE SAME PROCEDURE. 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 FRAGMENT WAS RETRIEVED USING A LAPAORSCOPIC GRASPER. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. ACCORDING TO THE CUSTOMER, IT WAS NOT NECESSARY TO PERFORM POST-OPERATIVE TESTS. THE FRAGMENT FELL WHILE DISSECTING FAT TISSUE (PERIHEPATIC). THE SURGEON DID NOT NOTICE ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT UNTIL THE SMALL PART FELL. THE CUSTOMER BELIEVED THAT SOMETHING RELATED WITH ULTRASONIC MOVEMENTS CAUSED THE INSTRUMENT TO BREAK. THE INSTRUMENT WAS USED FOR 20 MINUTES PRIOR TO THE ISSUE. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THERE WAS NO DAMAGE OR COLLISION BETWEEN INSTRUMENTS OR HARD MATERIAL.

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 INSTRUMENT TIP BROKE AND FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED IN THE SAME PROCEDURE. 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 INSTRUMENT WAS IN USE FOR APPROXIMATELY 5 MINUTES WHEN THE TIP BROKE WHILE DISSECTING. ACCORDING TO THE SURGEON, HE WAS FREEING THE THYROID GLAND ATTACHMENTS AND AS HE APPLIED ENERGY THERE WAS NO DESIRED EFFECT WHICH HE USUALLY GETS AND WHEN HE OPENED THE JAW THE INSTRUMENT TIP BROKE. THE FRAGMENT THAT FELL INTO THE PATIENT WAS RETRIEVED BY AN UNSPECIFIED HAND INSTRUMENT DURING THE SAME PROCEDURE. THE SURGEON VISUALLY CONFIRMED ALL FRAGMENTS WERE RETRIEVED. NO POST-OPERATIVE TESTS OR ADDITIONAL SURGICAL PROCEDURES WERE PERFORMED. IT WAS REPORTED THAT THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENT HAD NOT BEEN REMOVED PRIOR TO BREAKAGE. FURTHERMORE, IT WAS CONFIRMED THAT THERE WAS NO INJURY TO THE PATIENT AND THE PATIENT WAS DISCHARGED NORMALLY AND HAD NOT RETURNE

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, THE 8MM BLADELESS OBTURATOR INSTRUMENT TIP WAS BROKEN OFF AND FELL INSIDE THE PATIENT. THE TIP WAS NOT RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO OTHER REPORTED ISSUES. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE OPERATING ROOM (OR) MANAGER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE TIP OF THE 8MM BLADELESS OBTURATOR INSTRUMENT WAS NOT RETRIEVED. THE INSTRUMENT DID NOT MAKE CONTACT WITH ANY OTHER INSTRUMENT OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE OR MANAGER WAS NOT SURE IF THE INSTRUMENT WAS INSPECTED PRIOR TO USE OR IF THE INSTRUMENT WAS REMOVED DURING THE PROCEDURE. THE OR MANAGER WAS UNSURE IF ANY POST-OPERATIVE TESTS (X-RAY, ULTRA SOUND) WERE PERFORMED TO CHECK FOR THE TIP. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE OPERATION ROOM MANAGER NOTED THAT THE INSTRUMENT WOULD BE RETURNED TO ISI FOR FAILURE INVESTIGATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INSTRUMENT NOT GRABBING SUTURE. 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: ON 10-FEBRUARY-2020, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT # MW5092558 WITH THE FOLLOWING EVENT DESCRIPTION, "THE PATIENT SUFFERED VAGINAL DEHISCENCE 12 WEEKS AFTER RECEIVING A DA VINCI ROBOTIC HYSTERECTOMY. REQUIRED EMERGENCY SURGERY TO PREVENT BOWEL EVISCERATION AND DEATH." HOWEVER, THERE IS NO ADDITIONAL INFORMATION PROVIDED REGARDING THE DA VINCI SURGICAL SYSTEM, HOSPITAL SITE NAME, OR PATIENT. AS A RESULT, ISI COULD NOT PERFORM FOLLOW-UP INVESTIGATION TO OBTAIN ADDITIONAL INFORMATION REGARDING 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 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 UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, DISSECTION OF THE VAGINAL STUMP WAS PERFORMED, AND TISSUE WAS DAMAGED. ON (B)(6) 2020, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE STUMP OF THE VAGINA WAS INJURED DURING THE PROCEDURE. THE CAUSE OF THE INJURY WAS ATTRIBUTED TO THE SURGEON¿S MISJUDGMENT. THE SURGEON CONFIRMED THAT ANOTHER STITCH SHOULD HAVE BEEN PLACED. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS REQUIRED TO REPAIR THE VAGINAL STUMP. ADDITIONALLY, THE SURGEON STATED THAT THE EVENT DID NOT OCCUR AS A RESULT OF THE DA VINCI SURGICAL SYSTEM MALFUNCTION. THE SURGERY WAS COMPLETED AS PLANNED AND THE PATIENT HAS PROGRESSED WELL WITHOUT ANY PROBLEMS.

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 VIA A GENERAL PHYSICIAN INQUIRY THAT AFTER A COMPLETED DA VINCI-ASSISTED GYNECOLOGY PROCEDURE, POSSIBLY ON (B)(6) 2019, PATIENT INJURY WAS REPORTED. THE PATIENT RETURNED TO THE HOSPITAL SIX TO SEVEN DAYS POST DA VINCI PROCEDURE, POSSIBLY ON (B)(6)2019, FOR WHAT WAS DESCRIBED AS ¿REPAIR¿ AS THERE WAS AN OBSERVED ¿TROCAR INJURY¿ AND ¿BOWEL NECROSIS¿. FURTHER DETAIL WAS UNKNOWN. THE PATIENT¿S CURRENT STATUS IS ALSO UNKNOWN.

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 VENTRAL HERNIA REPAIR SURGICAL PROCEDURE, THE CUSTOMER NOTED A METAL SHAVING AFTER PASSING A NEEDLE THROUGH THE CANNULA. THE CUSTOMER REPORTEDLY ATTEMPTED TO GRAB THE SHAVING WITH A LAPAROSCOPIC INSTRUMENT BUT WAS NOT ABLE TO LOCATE IT. IT WAS REPORTED THAT THE CUSTOMER WAS NOT ABLE TO SEE THE SHAVING ON AN X-RAY AND WAS NOT SURE OF THE SOURCE OF THE SHAVING. THE SIZE AND SHAPE OF THE METAL SHAVING ARE UNKNOWN SINCE THE CUSTOMER DID NOT PROVIDE ANY DETAILS ON THEM. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER NOTICED THE SHAVING DURING INSTALLATION OF THE ENDOSCOPE. THE CUSTOMER WAS NOT ABLE TO IDENTIFY THE SOURCE OF THE SHAVING. THE CANNULA AND ENDOSCOPE WERE INSPECTED AFTER THE PROCEDURE AND NO VISIBLE DAMAGE WAS OBSERVED ON EITHER OF THEM. THE INSTRUMENTS USED AT THE TIME OF THE REPORTED EVENT DID NOT MAKE CONTACT WITH ANY OTHER INSTRUMENT OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENTS USED AT THE TIME OF THE REPORTED EVENT WERE NOT INSPECTED PRIOR TO USE. NO ADDITIONAL POST-OPERATIVE TESTS OR PROCEDURES WERE PERFORMED TO

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 REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI ASSISTED ROBOTIC PROCEDURES TITLED, ¿EXTRAPERITONEAL VERSUS TRANSPERITONEAL SINGLE-PORT ROBOTIC RADICAL PROSTATECTOMY: A COMPARATIVE ANALYSIS OF PERIOPERATIVE OUTCOMES", THE FOLLOWING EVENTS WERE REPORTED. 98 PATIENTS UNDERWENT SINGLE-PORT ROBOTIC PROSTATECTOMY USING THE DA VINCI SP ROBOTIC SYSTEM WITH EXTRAPERITONEAL (GROUP I (N=52)) VERSUS TRANSPERITONEAL (GROUP II (N=46)) APPROACH FROM SEPTEMBER 2018 TO JUNE 2019 WERE INCLUDED IN THE STUDY. THE MEAN OPERATIVE TIME WAS SIGNIFICANTLY SHORTER WITH THE EXTRAPERITONEAL APPROACH COMPARED TO THE TRANSPERITONEAL APPROACH (201± 37.5 VERSUS 248.2 ± 42.3 MIN). NO PATIENTS RECEIVED PERIOPERATIVE BLOOD TRANSFUSION AND THE ESTIMATED BLOOD LOSS WERE SIMILAR AS 145.7± 87.7 VERSUS 117.6± 93.7ML RESPECTIVELY. POSTOPERATIVE COMPLICATIONS WERE COMPARABLE BETWEEN THE TWO GROUPS (TABLE 1). THERE WAS A TOTAL OF 6 CASES THAT DEVELOPED GRADE II CLAVIEN-DINDO COMPLICATIONS WHICH INCLUDES URINARY TRACT INFECTION, ACUTE KIDNEY INJURY, PULMONARY EMBOLISM. THERE WERE A TOTAL OF 7 CASES THAT DEVELOPED GRADE IIIA CLAVIEN-DINDO COMPLICATIONS, WHICH INCLUDES LYMPHOCELE, PELVIC ABSCESS, PELVIC HEMATOMA, URI

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: TIP COVER WAS MISSING FROM ROBOTIC SCISSOR WHEN REMOVED FROM PT TROCAR DURING ROBOTIC SURGERY. EFFORTS MADE TO LOCATE WITH NO AVAIL. PT WAS BROUGHT BACK TO SURGERY ON (B)(6) 2019 TO REMOVE RETAINED TOP COVER. 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: 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 SINGLE-PORT (SP) EXTRAPERITONEAL PROSTATECTOMY PROCEDURE, THE PATIENT PRESENTED WITH A PNEUMOTHORAX. THIS WAS ONE OF THE SURGEON'S FIRST DA VINCI-ASSISTED SP CASES, AND THE DA VINCI AXIS PORT WAS NOT AVAILABLE BACK THEN. AS SUCH, THE SURGEON USED A MODIFIED 3RD PARTY GELPORT THAT THEY LEFT SLIGHTLY UNRAVELED IN ORDER TO ALLOW SOME ADDITIONAL ACCESS/WORKING SPACE. HOWEVER, THIS DID NOT CREATE A GREAT SEAL. HE BELIEVES THE CO2 TRAVELED UP THE RECTUS SHEATH TO THE MEDIASTINUM, AND THEN CAUSED THE PNEUMOTHORAX. FROM HIS RECOLLECTION, THE PATIENT PRESENTED WITH POST-OPERATIVE RESPIRATORY CONCERNS, LIKELY DYSPNEA, AND A CHEST X-RAY CONFIRMED THE PNEUMOTHORAX. THEY PUT IN A CHEST TUBE AND INVOLVED A PULMONOLOGIST, WHO MANAGED THAT ASPECT OF THE PATIENT'S CARE. THERE MAY HAVE BEEN SOME EXTRA HOSPITALIZATION, BUT THE PATIENT RECOVERED WELL, WITH NO SEQUELAE. THE SURGEON BELIEVED THE EXTRAPERITONEAL APPROACH MAY HAVE ALSO CONTRIBUTED TO THIS COMPLICATION, AS SOME PATIENTS CAN DEVELOP SUBCUTANEOUS EMPHYSEMA FROM CO2 WITH THIS KIND OF APPROACH. HE THOUGHT THAT THE PRESSURE THAT THEY WERE USING COULD HAVE ALSO BEEN TOO HIGH, WHICH MAY HAVE CONTRIBU

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 (B)(6) 2019, IQ, A (B)(6) Y/O MARRIED, MOTHER OF A THREE Y/O CHILD, UNDERWENT A MINIMALLY INVASIVE ROBOTIC HYSTERECTOMY FOR TREATMENT OF SYMPTOMATIC UTERINE TUMORS ASSUMED TO BE BENIGN FIBROID DISEASE OF (B)(6). THE OPERATING SURGEON WAS (B)(6) FROM "(B)(6) OB/GYN". THE DIAGNOSIS OF UTERINE LEIOMYOSARCOMA WAS PRE-OPERATIVELY MISSED IN THIS PT. ACCORDING TO THE PT, HER SURGEON EXPLAINED THAT HER MALIGNANT UTERINE TUMOR WAS MORCELLATED IN ORDER TO ACCOMPLISH THE SMALL INCISION ROBOTIC HYSTERECTOMY OPERATION. SHE REPORTS THAT SHE WAS NO PRE-OPERATIVELY INFORMED OF THE NEED FOR MORCELLATION AND THAT NO DISCUSSION TOOK PLACE REGARDING THE POSSIBILITY THAT A MISSED / OCCULT CANCER COULD MASQUERADE AS A FIBROID TUMOR AND BE SPREAD OR UPSTAGED BY MORCELLATION. IT IS UNCLEAR WHETHER THE SURGEON USED THE ROBOTIC EQUIPMENT AS A MORCELLATOR TO DISINTEGRATE THE UTERINE TISSUES / TUMORS OR IF A LAPAROSCOPIC POWER MORCELLATOR DEVICE WAS USED IN THE OPERATION - AND IF SO, WHETHER A CONTAINMENT BAG WAS USED. IRRESPECTIVE, THE PT UNDERWENT MORCELLATION OF HER CANCER DESPITE CONCERNING PRE-OPERATIVE CLINICAL CRITERIA AND WITHOUT HAVING BEEN INFORMED OF THE POTENTIALLY DEADLY RISK OF CANCER UPSTAGI

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 BY THE PATIENT'S HUSBAND THAT AFTER UNDERGOING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, HE WAS INFORMED BY THE HOSPITAL THAT HIS WIFE¿S BOWEL HAD BEEN ¿NICKED¿ OR ¿CUT.¿ PER THE PATIENT¿S HUSBAND, HE ALSO CLAIMED THAT THE HOSPITAL INDICATED THAT THE INJURY WAS PART OF NORMAL SURGICAL COMPLICATIONS. THE PATIENT¿S HUSBAND REPORTEDLY DID NOT UNDERSTAND WHY THE PATIENT WAS SENT HOME AFTER THE OPERATION FOR TWO HOURS, ONLY TO RETURN TO THE EMERGENCY ROOM (ER). ACCORDING TO THE PATIENT¿S HUSBAND, AS A RESULT OF THE BOWEL INJURY, HIS WIFE STAYED IN THE ICU FOR 10 DAYS AND RECEIVED A BLOOD TRANSFUSION. IN ADDITION, HE ALLEGED THAT THE PATIENT EXPERIENCED A HEART ATTACK BECAUSE OF BLOOD LOSS. ON 11/04/2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE PATIENT¿S HUSBAND AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: HE DID NOT KNOW IF THE PATIENT HAD UNDERGONE ANY PREVIOUS SURGICAL PROCEDURES PRIOR TO UNDERGOING A DA VINCI-ASSISTED VENTRAL HERNIA REPAIR PROCEDURE. ACCORDING THE PATIENT¿S HUSBAND, THE PATIENT WAS TO UNDERGO A ROBOTIC HERNIA PAIR PROCEDURE TO FIX ONE DEFECT. HOWEVER, 4 SEPARATE DEFECTS WERE IDENTIFIED AND R

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: STAPLE LINE FAILED DURING BRONCHIAL REINFLATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHEN REMOVING THE MONOPOLAR SCISSOR FROM THE ROBOTIC PORT, IT WAS NOTED THAT THE (DISPOSABLE) COVER TIP WAS MISSING. UPON LOOKING IT WAS STILL IN THE TROCAR AND TORN. IT WAS THEN REMOVED AND A NEW ONE WAS PLACED ON THE SCISSORS. NO HARM TO PT. 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: IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED NEPHRECTOMY PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE BLEEDING. AS A RESULT, THE PATIENT UNDERWENT A SPLENECTOMY VIA OPEN SURGERY ON AN UNSPECIFIED DATE. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE POST-OPERATIVE BLEEDING IS UNKNOWN. ON 10/18/2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES ASSOCIATE (CSA), AND THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT WAS OBTAINED: THE CSA WAS NOT PRESENT DURING THE DA VINCI-ASSISTED NEPHRECTOMY. ACCORDING TO THE CSA, SHE OVERHEARD A CONVERSATION IN THE HOSPITAL REGARDING THIS PATIENT. THE PATIENT REPORTEDLY EXPERIENCED A POST-OPERATIVE BLEED THAT RESULTED WITH A SPLENECTOMY. ON 10/18/2019, ISI ALSO CONTACTED THE ISI CLINICAL TERRITORY ASSOCIATE (CTA) WHO WAS PRESENT DURING THE DA VINCI-ASSISTED NEPHRECTOMY PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. ACCORDING TO THE CTA, THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTED MALFUNCTIONS OF THE DA VINCI SURGICAL SYSTEM. THERE WERE ALSO NO INTRA-OPERATIVE COMPLICATIONS.

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 GLASS PANE ON THE OPTICAL TIP OF THE 0 DEGREE 8MM ENDOSCOPE LED LIGHTS ALLEGEDLY "DISSOLVED." IT WAS UNKNOWN IF THE "DISSOLVED" PARTICLES OR SHARDS WERE INTRODUCED INTO THE PATIENT'S ANATOMY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED 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: IT WAS REPORTED THAT AFTER PERFORMING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON IDENTIFIED A URETER THAT WAS UNINTENTIONALLY DISSECTED. THE SURGEON REPORTEDLY HAD TO REPAIR THE URETER. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE OPERATIVE COMPLICATION IS UNKNOWN. 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 DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) PROCEDURE, THE EXTERNAL ILIAC ARTERY WAS DAMAGED AND BLEEDING OCCURRED. THE CASE WAS CONVERTED TO OPEN SURGERY. THE SURGEON DID NOT KNOW WHEN THE VESSEL WAS DAMAGED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ON 06/18/2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND 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 WAS REPORTED. THE EXTERNAL ILIAC ARTERY APPEARED TO HAVE BEEN ¿PRICKED.¿ HOWEVER, IT IS UNKNOWN WHEN THE VESSEL INJURY ACTUALLY OCCURRED DURING THE SURGICAL PROCEDURE. THE ESTIMATED BLOOD LOSS FROM THE VESSEL INJURY IS ALSO UNKNOWN. THE SURGEON ELECTED TO CONVERT THE SURGICAL PROCEDURE TO OPEN SURGERY DUE TO THE VESSEL INJURY, BLEEDING, AND SINCE THE PATIENT HAD A ¿WEAK HEART,¿ WAS HYPERTENSIVE, AND OBESE. THE PATIENT REPORTEDLY RECEIVED A BLOOD TRANSFUSION. THE PLANNED LOW ANTERIOR RESECTION PROCEDU

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 APRIL 10, 2019, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE FOLLOWING SOCIAL MEDIA POSTING: "I DONE FILED A COMPLAINT ON THE COLON SURGEON WHO USED THIS MACHINE ON MY COLON LAST JULY. I ENDED OFF AFTER A MONTH OF HAVING BLOATING AND GAS THIS LEAD TO A HOLE IN MY COLON AND NOW I GOT COLITIS CAUSE IF YOUR MESSED UP JUNK MACHINE. AND I AM SUING NO DOUBT ABOUT IT I COULD HAVE DIED 2 MONTHS AGO." ON 04/12/2019, ISI CONTACTED THE PATIENT AND THE FOLLOWING INFORMATION REGARDING THE ALLEGED EVENT WAS OBTAINED: THE PATIENT UNDERWENT COLON SURGERY ON AN UNSPECIFIED DATE IN 2018. A MONTH AFTER SURGERY, THE PATIENT STARTED HAVING "TUMMY PAINS AND A LOT OF PAIN." THE PATIENT ENDED UP HAVING DIAGNOSTIC LAPAROSCOPIC SURGERY ON (B)(6) 2019 AND A HOLE IN HER COLON WAS FOUND. SHE NOW HAS COLITIS. THE PATIENT BELIEVES THE DA VINCI SURGICAL SYSTEM CAUSED HER OPERATIVE COMPLICATIONS. THE PATIENT HAD HER SURGERIES PERFORMED IN (B)(6).

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, A MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY ALLEGEDLY TORE AND FELL INSIDE THE PATIENT¿S STOMACH. IT IS UNCLEAR IF THE WHOLE OR A FRAGMENT OF THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT. IT IS ALSO UNKNOWN IF THE MCS TIP COVER ACCESSORY OR FRAGMENT WAS FOUND AND RETRIEVED FROM THE PATIENT.

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 UNDERWENT A "PARTIAL NEPHROTIC ROBOTIC LAPAROSCOPIC PROCEDURE" ON (B)(6)2019 WHO WAS READMITTED TO THE HOSPITAL "FOUR DAYS AFTER HER SURGERY" ON (B)(6) 2021 EXHIBITING POST-OPERATIVE SYMPTOMS OF ¿REGURGITATED APPROXIMATE 30 TIMES DURING THE PREVIOUS NINE HOURS"; VOMITING "BLACK COFFEE GROUND MATERIAL THAT SMELLED OF FECES." A RE-OPERATION WAS PERFORMED TO REPAIR AN "8MM HOLE" THAT HAD BEEN ¿LEFT BY THE ARM OF THE TROCHAR" CAUSING THE PATIENT¿S BOWEL TO BECOME "HERNIATED AND STRANGULATED." THE PATIENT WAS REPORTED AS STABLE AND THE PATIENT WAS DISCHARGED. IT WAS ALSO ALLEGED THAT A "BROKEN MACHINE" WAS NOT "ADEQUATELY REPAIRED" PRIOR TO THE INITIAL PROCEDURE ON (B)(6) 2019. IT WAS ALSO ALLEGED THAT DURING THE INITIAL PROCEDURE ON (B)(6) 2019, THERE WAS A "NEED TO CONVERT TO AN OPEN PROCEDURE," THERE WERE "ADDITIONAL OR LARGER INCISIONS," THAT THERE WAS ¿EQUIPMENT FAILURE," AND THERE WERE "UNCONTROLLED ELECTRICAL CURRENTS" WITH "PARTS OF THE ROBOT BEING LEFT BEHIND," AND THERE WERE "TISSUE BURNS" DUE TO "THE SURGEON NOT BEING IN TOTAL CONTROL OF THE ROBOT." THE FOLLOWING ADDITIONAL