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 DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET LOCATION WAS RIGHT UPPER LUBE (RUL), AND THE PNEUMOTHORAX WAS DISCOVERED WHEN THE PHYSICIAN USED FLUOROSCOPY AND NOTICED THAT THE PATIENT HAD A PNEUMOTHORAX FROM THE IMAGE. A CHEST TUBE WAS PLACED IN THE PATIENT, AND COUPLE HOURS LATER THE CHEST TUBE WAS REMOVED AND THE PATIENT WAS RELEASED FROM THE HOSPITAL THE SAME DAY.

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 PROCEDURE THE ENDOSCOPE (SERIAL NUMBER (SN): (B)(4)) EXPERIENCED COMMUNICATION ISSUES WHEN INSTALLED. THE OPERATING ROOM STAFF RESEATED THE ENDOSCOPE WHEN THE ERRORS OCCURRED, BUT THE ISSUE PERSISTED. THE SITE POWER CYCLED THE SYSTEM, AND WHEN THE ENDOSCOPE WAS REINSTALLED THE ERRORS RETURNED. THE PATIENT BEGAN TO BLEED DURING THE TROUBLESHOOTING AND THE SITE CONVERTED TO OPEN RATHER THAN REPLACING THE ENDOSCOPE. THE PATIENT IS REPORTEDLY IN GOOD HEALTH AFTER THIS PROCEDURE. ON 19-JAN-2022, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE SURGEON OF THIS PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE ENDOSCOPE ISSUES OCCURRED AT THE END OF THE PROCEDURE WHEN THE SURGEON WAS REMOVING THE TUMOR. THE PATIENT'S SPLEEN WAS SCRAPED AND ABOUT 50CC'S OF BLOOD WAS LOST IN TOTAL DUE TO THIS EVENT. THE SURGEON SAID THE BLEEDING WAS RESOLVED BY PLACING PRESSURE ON THE TISSUE.

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 DAVINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE BLEEDING AND RETURNED TO THE FACILITY FOR TREATMENT. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION. ON AN UNSPECIFIED POSTOPERATIVE DAY, THE PATIENT PRESENTED WITH HYPOTENSIVE SYMPTOMS. A CT SCAN REVEALED A HEMATOMA. THE SURGEON STATED HE BELIEVES THE POST-OPERATIVE BLEEDING WAS FROM THE RIGHT GASTROEPIPLOIC OR THE SHORT GASTRIC VESSEL AND WAS RELATED TO THE USE OF A SYNCHROSEAL INSTRUMENT ON THOSE VESSELS. THE SURGEON DOES NOT SKELETONIZE THE VESSELS BEFORE SEALING. THE SURGEON STATED HE DOES NOT LIKE HOW THE SYNCHROSEAL CUTS AND HAS TO CUT THE VESSEL MORE THAN ONCE. THE SURGEON INDICATED THAT HE HAS NEVER HAD POST-OPERATIVE BLEEDING INCIDENTS IN HIS PREVIOUS PROCEDURES AND HENCE WILL REVERT TO USING THE VESSEL SEALER EXTEND INSTRUMENT. THE SURGEON CONFIRMED NO SURGICAL INTERVENTION OR BLOOD TRANSFUSIONS WERE RENDERED TO THE PATIENT. HOWEVER, THE PATIENT WAS HOSPITALIZED FOR IV FLUIDS, BLOOD WORK, CT SCAN, AND OBSERVATION.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A TKA SURGERY WITH ROSA INSTRUMENTATION, THE PLANNED DISTAL FEMUR CUT WAS 7/9.5MM. THE CUT BONE AND VALIDATED CUT WAS OVER RESECTED AT 10/12.5MM. THERE WAS NO ADDITIONAL IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER 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: REFER TO DEVICE MANUFACTUER NARRATIVE FOR FOLLOW-UP INFORMATION.

S6 Robotic Vacuum — Robot vacuum cleaner. The product is sold online, in particular via Amazon. Hazard (Electric shock): The product is supplied with a non-EU (US) connector with a dangerous adapter; when plugged in, high-voltage live parts are accessible. The pins of the adaptor of the power supply are not insulated. The pin ends are neither properly rounded nor tapered. As a consequence, the user could touch live parts and receive an electric shock. The product does not comply with the requirements of the Low ...

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 INSTRUMENT WAS FOUND TO HAVE THE TEFLON PAD MELTED, AND FRAGMENTS WERE FALLING INSIDE THE PATIENT. THE FRAGMENTS WERE NOT RETRIEVED. THE CUSTOMER REMOVED THE INSTRUMENT AND USED A BACKUP INSTRUMENT TO COMPLETE THE PROCEDURE. 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 TEFLON PAD MELTED LIKE POWDER AS SOON AS THE CUSTOMER STARTED TO USE THE INSTRUMENT. THE FRAGMENTS WERE NOT RETRIEVED AS THEY WERE NOTED TO BE "LIKE POWDER." IT WAS UNKNOWN WHAT CAUSED THE MELTING TO OCCUR AS THE INSTRUMENT DID NOT COLLIDE WITH ANY HARD MATERIALS OR OTHER INSTRUMENTS, AND THE CUSTOMER CONFIRMED THAT ARCING WAS NOT OBSERVED. THE THYROID TISSUE DID NOT APPEAR TO BE TOO THICK. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED, AND NO ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICA

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A TKA SURGERY WITH ROSA INSTRUMENTATION THE TIBIA WAS OVER-RESECTED BY 2MM MEDIALLY AND 3.5MM LATERALLY. DUE TO THIS DEVIATION FROM THE SURGICAL PLAN, A 16MM TIBIAL IMPLANT WAS NEEDED WHEN A 10MM IMPLANT WAS PLANNED. PATIENT HAD NO IMPACT AND WAS NOT AFFECTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER 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 REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, HALF OF THE TIP FROM A HARMONIC ACE INSTRUMENT BROKE OFF IN THE ABDOMINAL CAVITY DURING LIVER RESECTION. THE FRAGMENT WAS RETRIEVED IN THE SAME PROCEDURE. NO OTHER INFORMATION WAS PROVIDED. ON (B)(6) 2022, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION FROM THE ROBOTICS COORDINATOR. THE SURGEON WAS USING THE HARMONIC ACE INSTRUMENT DURING A PARTIAL LIVER RESECTION. THE CASE WAS ALMOST COMPLETED, BUT THE FRAGMENT BROKE DURING DISSECTION. THE TEAM NOTICED THIS WHEN THE SURGEON WAS MOVING THE INSTRUMENT TO A DIFFERENT AREA OF THE LIVER. THIS CAUSED A 20-30 MINUTE DELAY IN THE CASE. THE FRAGMENT WAS FOUND AND REMOVED FROM THE PATIENT DURING THE SAME PROCEDURE BY USING A LAPAROSCOPIC GRASPER. IT WAS CONFIRMED TO BE REMOVED VISUALLY SO NOT POST-OPERATIVE TESTS WERE NEEDED. BOTH THE FRAGMENT AND THE INSTRUMENT HAVE BEEN GIVEN TO RISK MANAGEMENT. THE CASE WAS LATER CONVERTED TO AN OPEN PROCEDURE DUE TO PATIENT ANATOMY AND NOT DUE TO THE MALFUNCTION OF THE INSTRUMENT.

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 MALIGNANT HYSTERECTOMY PROCEDURE, THE PANCREAS WAS INJURED DURING THE INSERTION OF THE AIR-SEAL PORT IN A PATIENT WITH A SMALL BODY HABITUS. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION: THE SOURCE OF BLEEDING WAS PANCREATIC TISSUE, WHICH WAS DAMAGED WHEN A THIRD-PARTY AIRSEAL PORT WAS INSERTED IN THE PATIENT. THE BLEEDING WAS INITIALLY STOPPED BY APPLYING COMPRESSION AND HEMOSTATIC POWDER. THE SURGEON BELIEVES THAT THE CAUSE OF THE PANCREATIC INJURY WAS DUE TO THE PETITE STATURE OF THE PATIENT AND THE CEPHALAD DIRECTION OF THE INSERTION OF THE AIRSEAL PORT. ACCORDING TO THE SURGEON, THERE WAS NO MALFUNCTION OF AN ISI PRODUCT THAT CAUSED THE PANCREATIC INJURY. AT THE END OF THE PROCEDURE, THE PANCREATIC INJURY, THAT WAS SUSTAINED DURING PORT PLACEMENT, BEGAN TO RE-BLEED. A HEPATOBILIARY PANCREATIC SURGEON WAS CALLED INTO THE OPERATION TO SUTURE THE PANCREAS TO ACHIEVE HEMOSTASIS. THE SURGEON BELIEVES THAT THE CAUSE OF THE RE-BLEEDING WAS DUE TO A PSEUDOANEURYSM FORMED DURING TISSUE DAMAGE, SUTURING, OR DECREASE IN THE INSUFFLATION PRESSURE. NO ADDITIONAL TISSUE RESECTION WAS REQUIR

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A TKA SURGERY USING ROSA INSTRUMENTATION, THE TIBIA WAS OVER-RESECTED BY 3MM POSTERIOR-LATERAL. THIS WAS VALIDATED USING CALIPERS. TISSUE RELEASES AND BONE RECUTS HAD TO BE MADE TO BALANCE THE KNEE. A THICKER POLY HAD TO BE USED THAN WOULD HAVE BEEN THE CASE IF ROSA HAD CORRECTLY CUT THE REQUIRED AMOUNT OF BONE. THERE WAS NO ADDITIONAL PATIENT IMPACT REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DR. PERFORMED AN I&D AND REVISED A MAKO TIBIAL INSERT THAT WAS ORIGINALLY DONE BY DR. ON (B)(6) 2021 DUE TO INFECTION. RIGHT KNEE.

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 PATIENT EXPERIENCED ADVERSE EFFECTS FOLLOWING SURGERY WHERE A SCREW WAS MISPLACED INTRA-OPERATIVELY.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING MEDICAL LITERATURE WAS REVIEWED: ROBOTIC BRONCHOSCOPY: FACTORS ASSOCIATED WITH DIAGNOSTIC ACCURACY OF ROBOTIC BRONCHOSCOPY WITH 12-MONTH FOLLOW-UP: AUTHORS: ABHINAV AGRAWAL, MD, ELLIOT HO, DO, UDIT CHADDHA, MBBS, BARIS DEMIRKOL, MD, SIVASUBRAMANIUM V. BHAVANI, MD, D. KYLE HOGARTH, MD, FCCP, SEPTIMIU MURGU, MD, FCCP. CITATION:DOI:HTTPS://DOI.ORG/10.1016/J.ATHORACSUR.2021.12.041. IT WAS REPORTED PNEUMOTHORAX AND PATIENT HOSPITALIZE . NO DEVICE ISSUES WERE REPORTED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING AN INITIAL ROSA INSTRUMENTATION TKA SURGERY BOTH ROSA AND CALIPER VALIDATIONS CONFIRMED THAT THE TIBIA WAS OVER-RESECTED BY 4MM MEDIALLY AND 3MM LATERALLY. THERE WAS NO ADDITIONAL PATIENT IMPACT REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A TKA PROCEDURE WHILE USING ROSA INSTRUMENTATION, THERE WAS AN OVER RESECTION FROM PLANNED TIBIAL CUT OF 6MM. A 16MM INLAY WAS USED AND THE KNEE WAS STABLE AND WELL BALANCED. AS OF THIS REPORT SUBMISSION THERE HAS BEEN NO ADDITIONAL PATIENT IMPACT REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Husqvarna Automower 435X AWD and Automower 535 AWD robotic lawnmowers — Battery may degrade after roughly 1,450 charging cycles and overheat, creating a fire risk. No injuries in Canada or the US; 5 international incidents where the malfunction damaged equipment. Husqvarna offered free battery replacement to units with 1,200+ cycles and two free software updates via the Automower Connect App to prevent degradation.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A TKA UTILIZING ROSA INSTRUMENTATION THE TIBIA WAS OVER RESECTED BOTH MEDIALLY AND LATERALLY 4MM. CALIPERS WERE USED TO VERIFY THAT EXCESSIVE BONE REMOVAL HAD OCCURRED. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A ROSA TKA SURGERY THE 4-IN-1 CUT WAS NOT ACCURATE AND LED TO AN OVER-RESECTION. THE OVER-RESECTION WAS ENOUGH TO NOTCH THE FEMUR. THERE WAS NO ADDITIONAL PATIENT IMPACT REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Today, the Toronto City Council voted to ban sidewalk robots until the council has the opportunity to further study the effects they have on the community.

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 DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET LOCATION WAS RIGHT UPPER LUBE (RUL), AND THE PNEUMOTHORAX WAS DISCOVERED DURING POST-PROCEDURE CHEST X-RAY. A CHEST TUBE WAS PLACED IN THE PATIENT AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE CHEST TUBE WAS REMOVED FOUR DAYS AFTER THE PLACEMENT 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 DURING A DA VINCI-ASSISTED ESOPHAGECTOMY TRANSTHORACIC-NECK ANASTOMOSIS SURGICAL PROCEDURE, A PIECE OF HARMONIC ACE INSTRUMENT BROKE INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED DURING THE SAME PROCEDURE. THE CUSTOMER USED A BACKUP INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER (NURSE) AND OBTAINED ADDITIONAL INFORMATION: THE CUSTOMER DID NOT NOTICE ANY DAMAGE ON THE INSTRUMENT PRIOR TO USE. THE BROKEN PIECE WAS RETRIEVED WITH A LAPAROSCOPIC GRASPER INSTRUMENT. NO POST-OPERATIVE TESTS WERE PERFORMED. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS DISLODGED FROM THE MCS INSTRUMENT AND DROPPED IN THE CAVITY UPON REMOVING THE INSTRUMENT FROM THE PATIENT. THE SCRUB TECHNICIAN NOTICED THAT AND NOTIFIED THE SURGEON IMMEDIATELY. THE SCOPE WAS INTRODUCED AGAIN TO FIND AND RETRIEVE THE MCS TIP COVER ACCESSORY FROM THE BOWELS OF THE PATIENT. 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 ROBOTICS COORDINATOR STATED THAT THEY WERE ABLE TO REMOVE THE MCS TIP COVER WITH ANOTHER DA VINCI INSTRUMENT WITH NO REPOT OF PATIENT INJURY. THERE WERE NO INSTRUMENT FUNCTIONAL ISSUES AND THERE WAS NO ISSUE WITH REMOVING THE MCS FROM THE PATIENT. THEY NOTICED THE MCS TIP COVER ACCESSORY WAS NOT ON THE MCS THE MOMENT THEY REMOVED THE INSTRUMENT FROM THE PATIENT. NO MEDICAL INTERVENTION WAS REQUIRED TO ADDRESS THE ISSUE. ELECTROLUBE WAS USED AFTER THE TIP COVER HAD BEEN INSTALLED; NOT PRIOR TO INSTALLATION. THE ROBOTICS COORDINATOR CLARIFIED THAT THEY ARE CONCERNED WITH USING THE MCS 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITHOUT LYMPHADENECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP CAME OFF OF THE MCS INSTRUMENT AND COULD NOT BE LOCATED. AN X-RAY WAS PERFORMED AND THE MCS TIP WAS NOT SEEN. THE INSTRUMENTS WERE REPORTEDLY INSPECTED PRIOR TO THE PROCEDURE AND NOTHING LOOKED OUT OF THE ORDINARY. THERE WAS NO COLLISION WITH ANY OTHER INSTRUMENT OR HARD MATERIALS DURING THE PROCEDURE. IT WAS UNKNOWN HOW LONG THE INSTRUMENT HAD BEEN IN USE WHEN THE ISSUE OCCURRED. ACCORDING TO THE NURSE, SHE AND THE SURGEON FELT THAT THE MCS TIP CAME OFF BECAUSE IT IS NOT ATTACHED TO THE INSTRUMENT AND SHOULD BE MORE SECURE. SHE MENTIONED THAT THE MCS TIP WAS VERY DIFFICULT TO INSTALL AND STATED THAT FUTURE DESIGNS SHOULD HAVE THE TIP PRE-INSTALLED. THE INSTRUMENT WILL NOT BE RETURNED FOR ANALYSIS SINCE THERE WAS NO INSTRUMENT ISSUE, AND THE MCS TIP CANNOT BE FOUND TO BE RETURNED. THE PATIENT HAS NOT RETURNED DUE TO ANY POST-SURGICAL 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 THYROIDECTOMY SURGICAL PROCEDURE, THE CUSTOMER NOTED THAT A SKILLED SURGEON ATTEMPTED TO USE THE HARMONIC ACE INSERT TO DISSOCIATE TISSUE, BUT THE BLADE WOULD NOT WORK. THE CUSTOMER REPLACED THE HARMONIC ACE INSERT WITH A BACK-UP DEVICE OF THE SAME KIND AND COMPLETED THE PROCEDURE WITH NO REPORTED INJURY. ON (B)(6) 2022, INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP AND OBTAINED THE FOLLOWING ADDITIONAL/UPDATED INFORMATION REGARDING THE REPORTED EVENT: THE BLADE OF THE HARMONIC ACE INSERT FELL INSIDE THE PATIENT AND WAS RETRIEVED IMMEDIATELY WITH OTHER INSTRUMENTS DURING THE SAME PROCEDURE. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. NO ADDITIONAL SURGICAL INTERVENTION WAS CONDUCTED.

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 CASE IN PROGRESS WITH 45 MM STAPLER. STAPLER CLAMPED DOWN ON TISSUE AND WAS NOT ABLE TO DISCONNECT. SURGEON PRESSED EMERGENCY RELEASE BUTTON ON CONSOLE AND ASSIST USED EMERGENCY SCREW TO UNLOCK STAPLER FROM PATIENT WITH NO SUCCESS. DAVINCI REP CALLED AND CAME IN TO ASSIST. SURGEON WAS ABLE TO REMOVE STAPLER AND PROCEED WITH SURGERY. INSTRUMENT MALFUNCTION. WORKING WITH INTUIT REMOTELY, VENDOR WAS ABLE TO WORK WITH PHYSICIAN TO SUCCESSFULLY DISENGAGE STAPLER FROM BOWEL. INSTRUMENT WAS LABELLED AND REMOVED FROM SERVICE. VENDOR HAS SUBMITTED REQUEST FOR IR. A (B)(6) YEAR OLD MALE WITH QUADRIPLEGIA SUSTAINED AFTER DIVING INTO 3 FT OF WATER. HE UNDERWENT C4-5/6 ACDF WITH PLATING ON (B)(6) 2021. HE WAS INTUBATED FOR RESPIRATORY DISTRESS AND HAD TRACH PLACED (B)(6) 2021. PEG PLACED ON (B)(6) 2021. HIS HOSPITAL COURSE WAS COMPLICATED BY BRADYCARDIA WITH ASYSTOLE, NEUROGENIC SHOCK AND MUCUS PLUGGING. LAST COLONOSCOPY ~ 3 YEARS AGO, HE DOES HAVE A HISTORY OF COLON POLYPS, NO KNOWN FAMILY HISTORY OF COLON CANCER. HISTORY OF UMBILICAL HERNIA REPAIR WITH MESH MANY YEARS AGO. HE IS NOW AT A FACILITY FOR REHABILITATION. WE HAVE BEEN CONSULTED FOR COLOSTOMY TO HELP EASE CARE. HE WISHES 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: ON 15-OCT-2021, INTUITIVE BECAME AWARE OF A JOURNAL OF GASTRIC CANCER ARTICLE TITLED, "INTRACORPOREAL ESOPHAGOJEJUNOSTOMY DURING REDUCED-PORT TOTALLY ROBOTIC GASTRECTOMY FOR PROXIMAL GASTRIC CANCER: A NOVEL APPLICATION OF THE SINGLE-SITE® PLUS 2-PORT SYSTEM" (CHOI, S., SON, T., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, POST-OPERATIVE COMPLICATIONS INVOLVING DA VINCI SURGICAL PROCEDURES WERE NOTED: "ANASTOMOSIS-RELATED COMPLICATIONS WERE OBSERVED IN 2 PATIENTS. THE PATIENT WAS DISCHARGED ON POD 6 AFTER PROXIMAL GASTRECTOMY AND WAS RE-ADMITTED 14 DAYS AFTER DISCHARGE. THE PATIENT DEVELOPED ESOPHAGOJEJUNOSTOMY LEAKAGE, WHICH WAS TREATED WITH ENDOSCOPIC STENT INSERTION. ANOTHER PATIENT DEVELOPED ESOPHAGOJEJUNOSTOMY SITE STENOSIS THAT REQUIRED ENDOSCOPIC DILATATION DURING HOSPITALIZATION, AFTER WHICH THE PATIENT WAS DISCHARGED ON POSTOPERATIVE DAY (POD) 29. THE OTHER PATIENT WHO UNDERWENT COMPLETION TOTAL GASTRECTOMY DEVELOPED AN INTESTINAL OBSTRUCTION THAT REQUIRED ADDITIONAL SURGERY (LAPAROSCOPIC SEGMENTAL RESECTION OF THE SMALL BOWEL), AFTER WHICH THE PATIENT WAS DISCHARGED ON POD 35." INTUITIVE SURGICAL, INC. (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 AFTER A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, A 3RD DEGREE BURN WAS OBSERVED AROUND THE TROCAR SITE WHERE THE CAMERA PORT WAS LOCATED (3¿- 4¿ ABOVE THE UMBILICUS). THERE WAS NO ENERGY USED TO MAKE THE SURGICAL PORT INCISION AND NO REPORT OF ARCING OF ELECTRICAL ENERGY DURING THE CASE. IT WAS BELIEVED THAT BOTH THE PATIENT¿S ANATOMY AND THE DA VINCI INSTRUMENTS AND/OR ACCESSORIES MAY HAVE CONTRIBUTED TO THE BURN. THE PATIENT¿S UTERUS WAS ENLARGED AT 30 CM. IT IS ALLEGED THAT ALONG WITH THE PATIENT¿S SMALL STATURE AND MOVEMENT OF THE INSTRUMENTS DURING THE CASE, AN OCCLUSION MAY HAVE OCCURRED MAKING IT DIFFICULT FOR THE SMOKE TO EVACUATE. THE DA VINCI SYSTEM, INSTRUMENTS AND ACCESSORIES USED DURING THE PROCEDURE WERE INSPECTED PRIOR TO USE, AND NO ABNORMALITIES WERE FOUND. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS REQUIRED AT THE TIME OF THE EVENT. ALSO, THE PATIENT DID NOT REQUIRE HOSPITALIZATION DUE TO THE BURN. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON REASSESSED THE INJURY AT THE PATIENT'S POST-OPERATIVE VISIT TWO WEEKS AFTER THE PROCEDURE. PER 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: 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: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

At 6:35 p.m. on November 3, 2021, an employee was performing maintenance work on a machine in the automotive engine parts manufacturing facility. As the employee performed maintenance on the tool brush inside the deenergized machine, his upper body was protruding through the part entry door on top of the machine. While working in this position, the energized gantry robot which moves parts to and from the individual machines across the crank shaft line, entered the employee's work zone and struck him. The employee was entangled and caught between the gantry's "grabber hand" and the side of the machine. The employee suffered fatal injuries due to entanglement at the waist level by the gantry and the inside of the machine causing bleeding, contusions, lacerations, and bruises in the upper arms, chest, head and rib cage areas.

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 DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE A PATIENT EXPERIENCED BLEEDING DURING THE BRONCHOALVEOLAR LAVAGE (BAL). THE RIGHT UPPER LOBE (RUL) WAS VISUALIZED AND BLEEDING WAS IDENTIFIED AND ORIGINATED FROM THE POSTERIOR SEGMENT. A DROP IN SATURATIONS REQUIRED MANUAL BAGGING FOR VENTILATION. THE BLEEDING WAS SUCCESSFULLY TREATED WITH EPINEPHRINE AND BALLOON TAMPONADE. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO SUBSEQUENT COMPLICATION. THE PATIENT WAS EXTUBATED IN THE OPERATING ROOM (OR) AND WAS ADMITTED FOR FURTHER OBSERVATION AND WAS RELEASED THE FOLLOWING DAY.

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 PERIESOPHAGEAL SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT DID NOT WORK TO STOP THE BLEEDING. IT IS UNCLEAR WHAT SURGICAL TASK THE SURGEON WAS ATTEMPTING TO PERFORM WHEN THE REPORTED EVENT OCCURRED. THE SURGEON HAD TO SWITCH TO A VESSEL SEALER EXTEND INSTRUMENT TO STOP THE BLEEDING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ISI EXECUTIVE SALES REPRESENTATIVE (ESR) WHO WAS PRESENT FOR THE PROCEDURE AND OBTAINED ADDITIONAL INFORMATION ON 16-NOV-2021. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE SYNCHROSEAL INSTRUMENT WAS NOT SEALING THE SHORT GASTRIC VESSELS ALONG THE GREATER CURVATURE OF THE STOMACH IN THE SYNCH AND SEAL MODES. THE CUTTING FUNCTION WAS WORKING IN THE SYNCH MODE BUT NOT THE SEALING FUNCTION ALTHOUGH THE GENERATOR GAVE THE APPROPRIATE TONES. AS A RESULT, THE VESSELS WERE OOZING/ BLEEDING. THE ESTIMATED BLOOD LOSS WAS LESS THAN 750 ML. THE SURGEON THEN USED A VESSEL SEALER EXTEND INSTRUMENT TO OBTAIN CONTROL AND STOP THE BLEEDING FROM THE SHORT GASTRIC VESSELS. THERE WERE NO ERRORS THAT OCCURRED AT THE TIME OF THE INC

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: IT WAS REPORTED THAT DURING A TKA SURGERY WITH ROBOTIC INSTRUMENTATION THE SURGEON PLANNED FOR TIBIA 0 DEGREE V/V CUT BUT ENDED UP IN 7 DEGREE VARUS (FROM POST-OP X-RAY). THE ROBOTIC SYSTEM SUGGESTED TIBIA BONE CUT OF 11.5MM ON LATERAL AND 9MM ON MEDIAL. THE VERIFIED CUT WAS 9MM MEDIAL AND 12MM LATERAL. VERIFICATION SHOWED 1 DEGREE OF VALGUS. FROM PRE-OP X-RAY TEMPLATING, SURGEON SHOULD HAVE CUT 12MM ON LATERAL AND 4MM ON MEDIAL TO GET THE KNEE STRAIGHT. NO MID SURGERY INTERVENTION OCCURRED. SURGEON EXECUTED THE SURGERY THAT WAS ORIGINALLY PLANNED. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

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 ESOPHAGECTOMY TRANSTHORACIC CHEST ANASTOMOSIS SURGICAL PROCEDURE, THE METAL TIP OF THE HARMONIC ACE INSTRUMENT BROKE OFF. THE FRAGMENT WAS RETRIEVED DURING THE PROCEDURE. THE CUSTOMER WAS TAKING OUT TISSUE WHEN THE INSTRUMENT BROKE. THE INSTRUMENT WRIST STRAIGHTENED UPON REMOVAL. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS. 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 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 SMALL PNEUMOTHORAX. THE PNEUMOTHORAX WAS DISCOVERED DURING POST-OP CHECK VIA A CHEST X-RAY. THE LOCATION OF THE PNEUMOTHORAX WAS LEFT UPPER LOBE (LUL). THE PNEUMOTHORAX WAS TREATED EXPECTANTLY WITH OXYGEN AND HOSPITALIZATION ON (B)(6) 2021. A SECOND CHEST X-RAY WAS TAKEN, AND PNEUMOTHORAX WAS RESOLVED, AND THE PATIENT WAS DISCHARGED ON (B)(6) 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, TIP OF THE HARMONIC ACE INSTRUMENT BROKE AND FELL INSIDE THE PATIENT. THE CUSTOMER WAS ABLE TO RETRIEVE THE FRAGMENT IN THE SAME PROCEDURE. THE FRAGMENT AND THE INSTRUMENT WILL BE RETURNED FOR EVALUATION. THEY WERE DISSECTING WHEN THE FRAGMENT FELL INSIDE THE PATIENT. THERE WAS NO TIP OR INSTRUMENT COLLISION. THE WRIST OF THE INSTRUMENT WAS STRAIGHTENED UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ORIGINAL REPORTER AND OBTAINED ADDITIONAL INFORMATION ON 15-NOV-2021. THE INSTRUMENT WAS INSPECTED IN THE NORMAL PRE-OPERATION INSPECTION AND NOTHING OUT OF THE ORDINARY WAS NOTED. THE INSTRUMENT WAS USED FOR APPROXIMATELY 1.5 HOURS. THE FRAGMENT WAS RETRIEVED BY THE BEDSIDE ASSIST USING A LAPARSCOPIC INSTRUMENT. BOTH THE INSTRUMENT AND THE FRAGMENT WERE GIVEN TO THE MATERIALS DEPARTMENT TO COMPLETE THE RETURN. NO INJURY WAS OBSERVED TO THE PATIENT AT THE TIME OF THE ISSUE. HE WAS NOT AWARE IF ANY POST-OPERATIVE TESTS WERE PERFORMED TO VERIFY ALL FRAGMENTS WERE RETRIEVED AND HE WAS NOT AWARE IF THE PATIENT HAD EXPERIENCED ANY POST-SURGICAL COM

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 DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE LOCATION OF THE TARGET AND PNEUMOTHORAX WAS LEFT UPPER LOBE. IN ADDITION TO THE PNEUMOTHORAX, THE PATIENT SUFFERED AN ALLERGIC REACTION TO ANESTHETIC. A CHEST TUBE WAS PLACED TO TREAT THE PNEUMOTHORAX. THE CHEST TUBE WAS REMOVED, AND PATIENT WAS DISCHARGED ON (B)(6) 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.

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 REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) WITH TOTAL MESORECTAL EXCISION (TME) AND LOW ANASTOMOSIS ON (B)(6) 2021, THE PATIENT WAS DISCHARGED ON POST-OPERATIVE DAY (POD) #2, THE PATIENT DEVELOPED A POST-OPERATIVE INFECTION ON POD #13. THE UMBILICAL INCISION HAD ECCHYMOSIS CONSISTENT WITH PRESSURE FROM THE ROBOT AND SOME SEROUS DRAINAGE WAS OBSERVED. THE INCISION WAS OPENED, AND THE SEROSANGUINOUS DRAINAGE WAS EXPELLED. THE WOUND WAS THEN PACKED WITH ½-INCH IODOFORM, COVERED WITH 4X4 GAUZE. THE INFECTION WAS RESOLVED BY POD #43.

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 REVISION SURGERY WAS DONE TO REPOSITION A MISPLACED L5 RIGHT SCREW.

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 SITE¿S ROBOTIC COORDINATOR TO INTUITIVE SURGICAL INC, (ISI) CUSTOMER SERVICE, THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY, THE SYNCHROSEAL INSTRUMENT ALLEGEDLY MISFIRED AND DID NOT ADEQUATELY SEAL A VESSEL. AS A RESULT, BLEEDING WAS OBSERVED. ON 02-NOV-2021, ISI OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM A SITE ROBOTICS NURSE, STEMMING FROM INFORMATION PROVIDED BY OPERATING ROOM (OR) STAFF WHO WERE PRESENT FOR THE CASE: THE SYNCHROSEAL INSTRUMENT DID NOT ACTIVATE AT ONE TIME DURING THE SURGICAL PROCEDURE BUT THE PHYSICIAN CONTINUED TO USE THE DEVICE. A SECOND BACKUP INSTRUMENT WAS NOT OPENED AND USED DURING THE CASE. THE ROBOTICS NURSE IS UNSURE OF THE AMOUNT OF BLOOD LOSS AND CONFIRMED THAT THE INSTRUMENT WAS RETURNED FOR EVALUATION. NO OTHER ADDITIONAL INFORMATION WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED LOBECTOMY PROCEDURE, DURING "VASCULARIZATION" OF THE HILAR REGION OF THE LUNG, THE PATIENT EXPERIENCED BLEEDING. THE CAUSE OF THE BLEEDING WAS NOT DISCLOSED. THE SURGEON COULD NOT CONTROL THE BLEEDING; MEDIUM-LARGE CLIPS WERE USED TO IN AN ATTEMPT TO CONTROL THE BLEED WITHOUT SUCCESS. AS A RESULT, THE SURGEON DECIDED TO CONVERT TO OPEN CHEST SURGERY. ON 25-OCT-2021, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: DURING A DA VINCI-ASSISTED RIGHT PULMONARY LOBECTOMY PROCEDURE, THE PATIENT EXPERIENCED BLEEDING DURING HILAR VASCULAR TREATMENT WITH THE SYNCHROSEAL INSTRUMENT. THE SURGEON INDICATED THAT THE CAUSE OF THE BLEED MIGHT HAVE BEEN RELATED TO "TENSION" OR DAMAGE TO AN UNSPECIFIED VESSEL WHEN "PEELING" AND "NOT CUTTING" WITH THE SYNCHROSEAL INSTRUMENT. IT IS UNCLEAR WHAT THE SURGEON MEANT BY "PEELING." THE SURGEON TRIED TO STOP THE BLEEDING WITH THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT AND SUCTIONING. THE SURGEON APPLIED JUST ONE CLIP BUT WAS UNABLE TO PLACE A SECOND CLIP FOR AN UNKNOWN REASON. THE SURGEON COULD NOT CONTROL THE BLEEDING. DUE TO THE

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 REVISION SURGERY WAS DONE TO REMOVE A MISPLACED LEFT SIDE SCREW FROM THE INITIAL OPERATION. THIS EVENT OCCURRED IN (B)(6).