Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING A REVISION OF T7 TO L2, WITH AN EXTENSION OF FUSION FROM T4 TO T7, USING A "UNID" ROD USING THE CT TO FLUORO WORKFLOW, THERE WAS AN ALLEGED INACCURACY. AFTER DISCUSSING THE CASE WITH THE SURGEON, IT WAS DECIDED THAT THEY WOULD BE PLACING SCREWS IN T4, T5, AND T6, AND REMOVING THE EXISTING HARDWARE AT T7 AND T8 AND REDIRECTING AND REPLACING THE SCREWS AT T7 AND T8. WHILE REGISTERING THE PATIENT TO THE ROBOTIC SYSTEM, THEY HAD GOTTEN SEGMENTATION ON THEIR FIRST AP AND OBLIQUE SHOTS, BUT WHEN IT WENT TO THE REGISTRATION, THEY GOT RED VALUES AT ALL LEVELS (T4-T8). THEY ADJUSTED THE NON-MEDTRONIC IMAGING SYSTEM AND TOOK A NEW OBLIQUE IMAGE AND THEY WERE ABLE TO GET SEGMENTATION AND GREEN VALUES ON THE SECOND REGISTRATION ATTEMPT. THEY CHECKED FOR SHIFTS AND NONE WERE NOTED SO THEY PROCEEDED TO THE OPERATE PORTION. THEY STARTED WITH T4 ON THE RIGHT AND WORKED THEIR WAY DOWN THE RIGHT SIDE, PLACING SCREWS IN T4, T5, AND T6. THE NEUROMONITORING TEAM RAN A MOTOR TEST AFTER THEY PUT IN THE 3 SCREWS ON THE RIGHT SIDE AND THERE WERE NO CHANGES. THE SITE THEN SWITCHED TO

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A SCREW WAS MISPLACED USING THE EXCELSIUS GPS SYSTEM.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER A PATIENT, WHO WAS ENROLLED IN A CLINICAL STUDY, UNDERWENT A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY PROCEDURE, A BIOPSY CLIP WAS REPORTED AS RETAINED IN THE PATIENT. AS A RESULT, THE PATIENT REQUIRED AN ADDITIONAL SURGICAL PROCEDURE TO RETRIEVE THE CLIP. THE INITIAL PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT COMPLICATIONS NOR DEVICE MALFUNCTIONS REPORTED. IT WAS LATER FOUND IN THE PATHOLOGY REPORT THAT THE BIOPSY CLIP WAS NOT OBSERVED IN THE SPECIMEN. THE RETRIEVAL OF THE SPECIMEN DURING THE PROCEDURE WAS REPORTED AS SMOOTH WITHOUT ISSUES. A CHEST X-RAY AND ULTRASOUND CONFIRMED THE CLIP WAS RETAINED IN THE PATIENT. AN ADDITIONAL SURGICAL EXCISION OF THE CLIP WAS REQUIRED USING WIRE LOCALIZATION. THE STUDY INVESTIGATOR ASSESSED THIS INCIDENT NOT RELATED TO THE DA VINCI DEVICES BUT RELATED TO THE PROCEDURE ITSELF.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE ANALYSIS OF 23 PATIENTS THAT UNDERWENT ROBOTIC-ASSISTED CYSTECTOMY WITH VARIOUS TYPES OF URINE DERIVATION OF BLADDER CANCER BETWEEN 2021 AND 2024. URINE DIVERSION BY UCS WAS PERFORMED IN 7 PATIENTS, AN ILEAL CONDUIT WAS FORMED USING THE BRICKER METHOD IN 6 PATIENTS, AND ORTHOTOPIC ILEOCYSTOPLASTY ACCORDING TO STUDER WAS PERFORMED IN 10 PATIENTS. IN THE EARLY POSTOPERA­TIVE PERIOD, COMPLICATIONS DEVELOPED IN 9 (39%) PATIENTS WITHIN 1¿16 DAYS AFTER SURGERY. IN MOST CASES, THIS WAS OBSTRUCTIVE PYELONEPHRITIS, WHICH REQUIRED PERCUTANEOUS PUNCTURE NEPHROSTOMY, WHICH CLASSIFIED AS CLAVIEN¿DINDO IIIA. NEPHROSTOMIES WERE CLOSED AFTER THE RESOLUTION OF PYELONEPHRITIS AND RESTORATION OF URINATION. IN ONE PATIENT WHO UNDERWENT CYSTOPROSTATECTOMY WITH EXTENDED PELVIC LYMPHADENECTOMY, LAPAROTOMY WAS PERFORMED ON POSTOPERATIVE DAY 2 DUE TO A DECREASE IN THE HEMOGLO­BIN LEVEL. DURING THE REVISION, DIFFUSE TISSUE HEMORRHAGE WAS DETECTED, WHICH WAS STOPPED USING HEMOSTATIC SPONGES. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHOR ALLEGE THAT ISI PRODUCTS CAUSED OR CONTRIBUTED TO THE EVENT. MULTIPLE REQUESTS FOR ADDITIONA

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, DISLODGED TIPS AND WHITE LOOSE PART ON SYNCHOSEAL/EAGLE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME 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: WHEN FIRING THE ROBOTIC STAPLING DEVICE IT JAMMED AND LAID DOWN STAPLES, BUT DID NOT CUT THE BOWEL. THE AREA HAD TO BE RESECTED CAUSING SLIGHTLY INCREASED MARGINS.

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 THAT THE SINGLE PORT (SP) MONOPOLAR CURVED SCISSORS (MCS) TIP COVER CAME OFF WHEN DISSECTING A PEDICLE. THE SP MCS TIP COVER HAD A GAP BETWEEN THE INSTRUMENT TIP AND SHEATH. THE RUBBER REPORTEDLY CAME OFF, BUT THE BLADE SET STAYED ON. THE SURGEON SPENT 15 MINUTES FINDING THE SP TIP COVER. REPORTEDLY WHEN THE SURGEON HAD EXPERIENCED A LOOSE SP MCS TIP COVER, THE INSTRUMENT WAS REPLACED WITH A NEW SP MCS INSTRUMENT AND TIP COVER. THE PROCEDURE WAS COMPLETED.

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 SHOULDER PROCEDURE, REAMING RESULTED IN AN OBLONG HOLE DUE TO HARD BONE. THE SURGEON GRAFTED THE OBLONG DEFECT CREATED BY THE REAMING. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, 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: A REVIEW OF A LITERATURE ARTICLE CONCERNING A DA VINCI ROBOTIC NIPPLE SPARING MASTECTOMY AND IMMEDIATE BREAST RECONSTRUCTION (RNSMIBR) WITH GEL IMPLANT WAS PERFORMED. THE AIM OF THE STUDY WAS TO ANALYZE THE EFFECT OF THE DA VINCI ROBOT IN NIPPLE-PRESERVING AREOLA-PRESERVING IMMEDIATE PROSTHETIC BREAST RECONSTRUCTION. SURGERIES WERE REVIEWED BETWEEN THE TIME PERIOD OF SEPTEMBER 2022 TO MAY 2024 USING THE DA VINCI SI AND XI SYSTEMS. A TOTAL OF 116 FEMALE PATIENTS WERE INCLUDED. A TOTAL OF 14 PATIENTS UNDERWENT SURGERY USING THE DA VINCI SI SURGICAL SYSTEM AND 102 PATIENTS UNDERWENT SURGERY USING THE DA VINCI XI SURGICAL SYSTEM. THE ARTICLE STATED THERE WERE "TWO CASES OF IMPLANTS LOSS AND FIVE CASES OF HEAT STEAM-INDUCED SKIN DAMAGE." THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, AND NO INDICATION THAT ISI PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. IT WAS CONCLUDED THAT THE DA VINCI ROBOTIC NIPPLE-PRESERVING AREOLA IMMEDIATE PROSTHESIS BREAST RECONSTRUCTION SURGERY CAN PROVIDE GOOD COSMETIC RESULTS WITHOUT SERIOUS PERIOPERATIVE COMPLICATIONS. ALSO, RNSMIBR CAN PROVIDE BETTER OVERALL AESTHETIC RESULTS AND PATIENT SATISFACTION, AND MAY DECREASE THE RISK OF NIP

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS PI IS FOR THE INITIAL CASE ON 21/JUNE/2024. ON FRIDAY 6/21 THERE WAS A RTHA 4.1 AND THE CUP ENDED UP ALMOST VERTICAL, I WOULD ESTIMATE 60-70 DEGREES OF INCLINATION. I WAS NOT IN THE CASE, BUT FROM WHAT I WAS TOLD BOTH THE ROBOT AND THE BONE WERE RE-REGISTERED. THIS EVENTUALLY LED TO A HIP REVISION ONCE THE PATIENT DISLOCATED.

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 LOW ANTERIOR RESECTION PROCEDURE, AN ABDOMINAL SURGICAL WOUND INFECTION WAS IDENTIFIED 22 DAYS POST-OPERATIVELY. THE NURSE OBSERVED REDNESS, SWELLING, HEAT, AND PAIN AROUND THE WOUND. THE RESIDENT PHYSICIAN EXAMINED THE WOUND, REMOVED ONE STITCH, AND EXPRESSED A LARGE AMOUNT OF FOUL-SMELLING PUS. A WOUND CULTURE WAS TAKEN, AND INSTRUCTIONS WERE GIVEN FOR WOUND PACKING AND DRAINAGE CARE EVERY 8 HOURS. BLOOD TESTS WERE SCHEDULED, AND A BLOOD CULTURE WAS PERFORMED. THE NEXT DAY, A DRAINAGE TUBE WAS PLACED IN THE LEFT ABDOMEN TO DRAIN AN ABDOMINAL ABSCESS. ONE WEEK LATER, THE LEFT ABDOMINAL DRAINAGE TUBE (DRAINAGE FLUID <2ML) WAS REMOVED. THE ATTENDING PHYSICIAN EXAMINED THE SUBJECT AND THE ABDOMINAL WOUND, AND IT WAS NOTED THAT THE SUBJECT COULD BE DISCHARGED IN 2-3 DAYS WITH CONTINUED OBSERVATION. ONE WEEK LATER, THE PATIENT WAS IN GOOD SPIRITS AND WITH GOOD ENERGY. THE WOUND IN THE RIGHT ABDOMEN HAD HEALED WITHOUT FURTHER PUS FORMATION, AND THERE WAS NO FEVER, SO DISCHARGE WAS APPROVED FOR THE SAME DAY. THERE IS NO REPORT THAT A DA VINCI DEVICE MALFUNCTIONED OR CAUSED OR CONTRIBUTED TO THE EVENT.

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE ANALYSIS BETWEEN JANUARY 2021 AND AUGUST 2023 OF 69 PATIENTS THAT UNDERWENT DA VINCI SINGLE PORT (SP) ASSISTED ROBOTIC HYSTERECTOMY WITH CONCOMITANT SACROCOLPOPEXY FOR PELVIC ORGAN PROLAPSE (POP) AT TWO TERTIARY CARE CENTERS, PERFORMED BY FIVE TRAINED SURGEONS. THE STUDY WAS CONDUCTED TO EVALUATE THE SHORT-TERM OUTCOMES OF THE PATIENTS UNDERWENT SP ASSISTED HYSTERECTOMY WITH CONCOMITANT SACROCOLPOPEXY POP. THE PROCEDURES WERE ALL COMPLETED EXCEPT FOR ONE CASE OF CONVERSION TO OPEN SURGERY. THE MEDIAN OPERATIVE TIME WAS 209 MINUTES, MEDIAN ESTIMATED BLOOD LOSS WAS 100ML. ONE PATIENT EXPERIENCED A MAJOR VASCULAR INJURY DURING PRESACRAL DISSECTION AND REQUIRED CONVERSION TO LAPAROTOMY. FIVE POST-OPERATIVE COMPLICATIONS WERE MENTIONED IN THE ARTICLE WHICH INCLUDED TWO CASES OF SMALL BOWEL OBSTRUCTION, ONE OF THEM WAS RESOLVED BY CONSERVATIVE MANAGEMENT, AND ONE REQUIRED SURGICAL MANAGEMENT. A PATIENT EXPERIENCED PELVIC HEMATOMA REQUIRING A BLOOD TRANSFUSION, AND 1 CASE OF VENTRAL HERNIA THAT REQUIRED SUBSEQUENT REPAIR. ONE PATIENT HAD VAGINAL MESH EXPOSURE, AND THE PATIENT ELECTED TO UNDERGO SURGICAL EXCISION. THERE WAS NO MENTION OF ANY D

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 GASTRECTOMY PROCEDURE, WHILE USING THE HARMONIC ACE CURVED SHEARS INSTRUMENT, AN INSTRUMENT BLADE BROKE OFF AND FELL INSIDE THE PATIENT. THE BROKEN BLADE WAS REMOVED WITH AN UNKNOWN FORCEPS INSTRUMENT DURING THE SAME SURGICAL PROCEDURE. IT WAS CONFIRMED THAT THE FALLEN BLADE WAS NOT CHIPPED AFTER REMOVAL. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS. THE PROCEDURE WAS COMPLETED ROBOTICALLY AS PLANNED.

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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY X-RAY DURING 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: IT WAS REPORTED THAT AFTER A DA VINCI ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE PERFORMED, THE PATIENT EXPERIENCED BLOODY STOOLS ON THE SAME DAY POST-SURGERY. ON POST-OPERATIVE DAY ONE, A COLONOSCOPY FOUND BLEEDING AT THE ANASTOMOSIS SITE. HEMOSTATIC CLIPS WERE APPLIED, AND THE BLEEDING WAS RESOLVED. THERE WERE NO ABNORMAL BOWEL MOVEMENTS AFTER EATING, AND THE SUBJECT WAS DISCHARGED ON POST-OPERATIVE DAY SEVEN. ON POST-OPERATIVE DAY NINE, THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF BLOODY STOOLS, DIZZINESS, AND RESPIRATORY DISCOMFORT. TREATMENT INCLUDED FASTING, ADMINISTRATION OF HEMOSTATIC INJECTIONS, INTRAVENOUS DRIP, AND BLOOD TRANSFUSION. A FEVER WAS IDENTIFIED, AND BLOOD CULTURES WERE DRAWN. A CONSULTATION WITH THE COLORECTAL DEPARTMENT RECOMMENDED CONTINUING THE PREVIOUS TREATMENT AND ARRANGING FOR HOSPITALIZATION. ON POST-OPERATIVE DAY 10, THE PATIENT WAS ADMITTED TO THE WARD AND CONTINUED WITH FASTING, HEMOSTATIC INJECTIONS, ANTIBIOTICS AND A BLOOD TRANSFUSION. ON POST-OPERATIVE DAY 11, THE PATIENT WAS STILL EXPERIENCING BLOODY STOOLS, AND THE PHYSICIAN STATED THERE WAS NO NEED FOR FURTHER SURGERY AT THE MOMENT, AS THE ANASTOMOSIS SITE IS HE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE STUDY THAT ASSESSED THE INTRAOPERATIVE AND SURGICAL OUTCOMES OF 200 PATIENTS BY A SINGLE SURGEON THAT UNDERWENT SINGLE PORT ROBOTIC-ASSISTED SACROCOLPOPEXY (SCP) TO TREAT PELVIC ORGAN PROLAPSE FROM APRIL 2020 TO AUGUST 2023 IN ONE INSTITUTION. ALL PROCEDURES WERE COMPLETED WITHOUT CONVERSIONS TO LAPAROSCOPY OR LAPAROTOMY. INTRAOPERATIVE COMPLICATIONS WERE NOTED AS FIVE INTRAOPERATIVE CYSTOTOMIES; TWO OF THEM OCCURRED DURING THE DISSECTION OF THE VESICOVAGINAL SPACE, AND ALL OF THEM WERE REPAIRED SUCCESSFULLY. THERE WERE 2 CASES OF BOWEL INJURIES, 4 VAGINAL WALL TEAR, AND 1 SACRAL VESSEL INJURY THAT WERE REPAIRED INTRA-OPERATIVELY. POST-OPERATIVELY, FOUR PATIENTS WERE FOUND WITH UMBILICAL WOUND HERNIAS WITH ONE ELECTING SURGICAL REPAIR. A PATIENT WAS FOUND WITH MESH EXPOSURE AND WAS MANAGED CONSERVATIVELY WITH TOPICAL ESTROGEN. THERE WAS NO DA VINCI DEVICE MALFUNCTIONS OR ISSUES MENTIONED IN THE ARTICLE. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION FROM THE DESIGNATED AUTHOR WERE MADE, BUT NO RESPONSE HAS BEEN RECEIVED.

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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND REMAINING SCREWS WERE THEN PLACED BY HAND.

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED DURING 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.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: GERLING, M., BAKER, M., STANTON, E., PYUN, J., CHALADOFF, E., PASSIAS, P., <(>&<)> BUSER, Z. (2024). CLOSING THE GAP: THE INCIDENCE OF COMPLICATIONS IN MINIMALLY INVASIVE TUBULAR, ENDOSCOPIC, AND ROBOTIC-ASSISTED TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURES. WORLD NEUROSURGERY. HTTPS://DOI.ORG/10.1016/J.WNEU.2024.06.101 SUMMARY: BACKGROUND: THE AIM OF THE CURRENT STUDY WAS TO COMPARE THE INCIDENCE OF POSTOPERATIVE COMPLICATIONS AMONG MINIMALLY INVASIVE SURGERY (MIS) TUBULAR, ENDOSCOPIC, AND ROBOT-ASSISTED TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) TECHNIQUES. METHODS: WE STUDIED CONSECUTIVE PATIENTS WHO UNDERWENT SINGLE-LEVEL OR MULTILEVEL TLIF BETWEEN 2020 AND 2022. PREOPERATIVE AND POSTOPERATIVE PATIENT-REPORTED OUTCOMES (VISUAL ANALOG SCALE LEG SCORE AND OSWESTRY DISABILITY INDEX), DEMOGRAPHIC, AND INTRAOPERATIVE VARIABLES WERE RECORDED. ONE-WAY ANALYSIS OF VARIANCE WITH BARTLETT¿S EQUAL-VARIANCE AND PEARSON CHI-SQUARED TESTS WERE USED. RESULTS: THE STUDY INCLUDED 170 TLIF PATIENTS: 107 (63%) TUBULAR, 42 (25%) ENDOSCOPIC, AND 21 (12%) ROBOT ASSISTED. ALL 3 TLIF TECHNIQUES HAD SIMILAR COMPLICATION RATES: TUBULAR 6 (5.6%), ENDOSCOPIC 2 (4.8%), AND ROBOT ASSISTED 1 (4.8%) 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 SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT TIP FRACTURED. THE USER COMPLETED THE PROCEDURE ROBOTICALLY WITH USING A BACKUP HARMONIC ACE INSTRUMENT. 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. THERE WAS NO INSTRUMENT COLLISION. A FRAGMENT FELL INSIDE OF THE PATIENT AND WAS RETRIEVED DURING THE SAME 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 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: A LITERATURE DESCRIBED A STUDY AIMED TO EVALUATE SEXUAL AND REPRODUCTIVE OUTCOMES OF 22 PATIENTS FOLLOWING POST-CHEMOTHERAPY ROBOT-ASSISTED RETROPERITONEAL UNILATERAL LYMPH NODE DISSECTION (PC-RRPLND) FOR NON-SEMINOMATOUS GERM CELL TUMORS (NSGCTS) AT A HIGH-VOLUME CANCER CENTER. AMONG THE PATIENTS INCLUDED IN THE STUDY, AN INTRAOPERATIVE COMPLICATION (VENA CAVA INJURY) WAS RECORDED, WITHOUT NEEDING PERIOPERATIVE BLOOD TRANSFUSION. NONE OF THE PATIENTS EXPERIENCED LATE POST-OPERATIVE COMPLICATIONS. RETROGRADE EJACULATION IS CONFIRMED TO BE ONE OF THE MOST COMMON COMPLICATIONS OF PC-RRPLND. THERE WERE NO DA VINCI DEVICE ISSUES REPORTED IN THE ARTICLE. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION FROM THE DESIGNATED AUTHOR WERE MADE, BUT NO RESPONSE HAS BEEN RECEIVED.

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 USING A HARMONIC ACE INSTRUMENT, THE BLADE BROKE, RESULTING IN POOR CUTTING AND A FRAGMENT FALLING INSIDE THE PATIENT. THE SURGEON WAS CUTTING THE LIVER PARENCHYMA WHEN A PIECE OF THE INSTRUMENT'S BLADE BROKE OFF INSIDE THE PATIENT. THE BLADE PIECE WAS RETRIEVED WITH A LAPAROSCOPIC FORCEPS. THE PROCEDURE WAS CONTINUED WITH A BACKUP HARMONIC ACE INSTRUMENT. THE STAFF CONFIRMED ALL PIECES WERE RETRIEVED BY CHECKING THE FRAGMENT OF THE DAMAGED BLADE AND ALIGNING IT WITH THE HARMONIC ACE INSTRUMENT BODY. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO REPORT OF 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 DURING A DA VINCI-ASSISTED SUBTOTAL GASTRECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE BLADE FRACTURED. IT WAS CONFIRMED THAT THE FRACTURED PART WAS COMPLETELY REMOVED, AND NO FRAGMENT REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BACKUP HARMONIC ACE INSTRUMENT.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CITATION: SRINIVASA, V., THIRUGNANAM, B., PAI KANHANGAD, M., SONI, A., KASHYAP, A., VIDYADHARA, A., & RAO, S. K. (2024). FLATTENING THE LEARNING CURVE ¿ EARLY EXPERIENCE OF ROBOTIC-ASSISTED PEDICLE SCREW PLACEMENT IN SPINE SURGERY. JOURNAL OF ORTHOPAEDICS, 57, 49¿54. HTTPS://DOI.ORG/10.1016/J.JOR.2024.06.011. SUMMARY: AIMS AND OBJECTIVES: TO DETERMINE ACCURACY OF PEDICLE SCREWS PLACED BY FREEHAND, FLUOROSCOPY-ASSISTANCE AND ROBOTIC-ASSISTANCE WITH INTRAOPERATIVE IMAGE ACQUISITION, AND DETERMINE THE PRESENCE OF LEARNING CURVE IN ROBOTIC SPINE SURGERY IN A PROSPECTIVE SINGLE CENTRE STUDY. MATERIALS AND METHODS: IN A PROSPECTIVE STUDY, A TOTAL OF 1120 PEDICLE SCREWS WERE PLACED IN FREEHAND GROUP (N = 175), 1250 SCREWS WERE PLACED IN FLUOROSCOPY ASSISTED GROUP (N = 172), AND 1225 SCREWS WERE INSERTED IN ROBOTIC-ASSISTED GROUP(N = 180). SURGICAL PARAMETERS AND SCREW ACCURACY WERE ANALYZED BETWEEN THE THREE GROUPS. THE PREOPERATIVE PLAN WAS OVERLAPPED WITH POST OPERATIVE O-ARM SCAN TO DETERMINE IF THE SCREWS WERE EXECUTED AS PLANNED. RESULTS: THE FREQUENCY OF CLINICALLY ACCEPTABLE SCREW PLACEMENT (GERTZBEIN AND ROBBINS GRADE A, B) IN THE FREEHAND, FLUOROSCOPY-ASSISTED, AND ROBOTIC-ASSIST

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 ENERGY CABLE WAS UNABLE TO TRANSMIT ENERGY. THE USER CONVERTED TO OPEN SURGERY WITH A PROCEDURE DELAY GREATER THAN 30 MINUTES. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP 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.

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 DURING THE MONARCH BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A BLEED. THE PHYSICIAN REPORTED THE BLEEDING WAS NOT DUE TO MONARCH BUT RATHER JUST A RISK OF BIOPSYING THIS SPECIFIC PATIENT. THE PATIENT WAS ADMITTED FOR OBSERVATION ONLY.

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 PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON AN MCS INSTRUMENT, FELL INSIDE THE PATIENT'S PELVIS. THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE WHICH WAS COMPLETED ROBOTICALLY AND THE CUSTOMER CONFIRMED ALL PIECES WERE RETRIEVED BY A VISUAL INSPECTION. THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY WILL NOT BE RETURNED FOR FAILURE ANALYSIS EVALUATION. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING 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: 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: A LITERATURE ARTICLE DESCRIBED A STUDY THAT AIMED TO ANALYZE THE OUTCOMES OF 29 PATIENTS THAT UNDERWENT ROBOTIC-ASSISTED REVISIONAL ROUX-EN-Y GASTRIC BYPASS (RRYGB) SURGERIES FROM JANUARY 2016 TO FEBRUARY 2023 IN ONE SINGLE INSTITUTION. THE ARTICLE NOTED THAT AMONG THESE SURGERIES, ONE PATIENT EXPERIENCED A POST-OPERATIVE COMPLICATION OF JEJUNOJEJUNAL STENOSIS AND WAS RESOLVED BY REDOING THE JEJUNO-JEJUNAL ANASTOMOSIS LAPAROSCOPICALLY. THERE WERE NO POSTOPERATIVE ANASTOMOTIC LEAKS OR INCIDENCE OF HEMORRHAGE. THERE WERE NO DA VINCI DEVICE ISSUES REPORTED IN THE ARTICLE NOR ANY MORTALITY IN THE COHORT. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THERE WAS A RED TAG ERROR DURING CASE SET UP. "PIB HARDWARE COMMUNICATION STOPPED."

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND. THIS EVENT OCCURRED 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: A LITERATURE ARTICLE DESCRIBED AN OBSERVATIONAL COHORT STUDY WHICH WAS TO ASSESS THE IMPACT OF A PROFICIENCY-BASED PROGRESSION TRAINING CURRICULUM ON PERI-OPERATIVE AND SURVIVAL OUTCOMES FOR ENDOMETRIAL CANCER. THE STUDY OCCURRED FROM 2015 TO 2022 AND INCLUDED 594 WOMEN DIAGNOSED WITH PRIMARY ENDOMETRIAL CANCER TREATED WITH ROBOT-ASSISTED LAPAROSCOPIC SURGERY, WHICH TYPICALLY INVOLVED HYSTERECTOMY AND SALPINGO-OOPHORECTOMY ALONG WITH SOME FORM OF PELVIC LYMPH NODE DISSECTION. THE ARTICLE STATED MANY INTRAOPERATIVE COMPLICATIONS, WHICH WERE SLIGHTLY LOWER IN THE NON-TRAINING GROUP AT 4.8% COMPARED TO 7.7% IN THE TRAINING GROUP. GRADES 3A AND 3B COMPLICATIONS OCCURRED AT SIMILAR LOW FREQUENCIES ACROSS BOTH GROUPS, WHILE GRADE 4A COMPLICATIONS WERE EQUALLY RARE AT 0.7% IN BOTH GROUPS. READMISSION RATES WITHIN 30 DAYS WERE LOWER IN THE TRAINING GROUP (3.8%) COMPARED TO THE NON-TRAINING GROUP (6.0%). RETURNS TO THE THEATER WERE INFREQUENT IN BOTH GROUPS, OCCURRING AT 1.0% IN THE TRAINING GROUP AND 1.7% IN THE NON-TRAINING GROUP. LYMPHOEDEMA RATES WERE ALSO COMPARABLE, NOTED AT 8.4% IN THE TRAINING GROUP VERSUS 11.3% IN THE NON-TRAINING GROUP. THERE WERE NO DA VINCI DEVICE ISSUES MENTION

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE PATIENT DEVELOPED A PULMONARY EMBOLISM (PE) ALONG WITH RIGHT VENTRICULAR STRAIN ON POSTOPERATIVE DAY ONE AND WAS IN CRITICAL CONDITION. THE PATIENT'S CURRENT STATUS IS UNKNOWN. THE INITIAL PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO REPORTED INTRAOPERATIVE COMPLICATIONS OR MALFUNCTION OF THE DA VINCI SYSTEM. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN RECEIVED.

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 DURING SURGERY OF A BIOPSY AND LITT PROCEDURE, THE FIDUCIAL REGISTRATION WAS PERFORMED. THE BIOPSY AND PLACEMENT OF THE LITT BOLT OCCURRED WITHOUT INCIDENT. DURING THE INTRAOPERATIVE MRI SCAN TO BEGIN THE LITT ABLATION, SURGEON NOTICED WHAT APPEARED TO BE A HEMORRHAGE IN THE PATIENT'S TEMPORAL LOBE NEAR THE LASER FIBER. SURGEON TRANSITIONED THE SURGERY TO AN OPEN CRANIOTOMY TO TREAT THE HEMORRHAGE. REPORTER IS CURRENTLY UNAWARE AT THIS TIME OF THE PATIENT'S CONDITION AFTER SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A RETROSPECTIVE, COHORT STUDY WHICH DESCRIBED A COMPARISON BETWEEN ROBOTIC SINGLE-SITE (RSS) AND MULTIPORT LAPAROSCOPIC (MPL) SURGERY, WAS SUMMARIZED IN A LITERATURE ARTICLE. THE AIM OF THE STUDY WAS TO COMPARE RSS SURGERY TO MULTIPORT LAPAROSCOPIC SURGERY IN TERMS OF SURGICAL OUTCOMES AND OVERALL SURVIVAL FOR PATIENTS WITH EARLY ENDOMETRIAL CANCER. THE STUDY OCCURRED FROM MARCH 2014 TO DECEMBER 2022 AND INCLUDED A TOTAL OF 421 PATIENTS OF WHICH 146 UNDERWENT RSS SURGERY WITH A MEDIAN AGE OF APPROXIMATELY 51.95 YEARS AND A MEDIAN BMI OF 24.82. ALL PATIENTS WERE FEMALE AS THE STUDY INVOLVED ENDOMETRIAL CANCER PATIENTS. THE ARTICLE NOTED THAT DURING THESE SURGERIES, PERIOPERATIVE COMPLICATIONS OCCURRED INCLUDING: ONE CASE OF AN INCISIONAL HERNIA, ONE CASE OF LYMPHOCELE, ONE CASE OF RECTUM TEAR, ONE OCCURRENCE OF VAGINAL CUFF BLEEDING, ONE CASE OF VAGINAL CUFF DISRUPTION, AND ONE CASE OF VAGINAL CUFF INFECTION. THERE WERE NO REPORTS OF ANY DA VINCI DEVICE MALFUNCTIONS NOR WERE THERE ANY ALLEGATIONS THAT ANY INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. ADDITIONAL INFORMATION WAS REQUESTED FROM THE DESIGNATED AUTHOR; HOWEVER, NO RESPONSE WAS RECEIV

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 CHEST ANASTOMOSIS ESOPHAGECTOMY TRANSTHORACIC SURGICAL PROCEDURE THAT THE TIP OF THE HARMONIC ACE INSTRUMENT WAS FOUND TO BE LOOSE. REPORTEDLY A FRAGMENT FELL INTO THE PATIENT BUT WAS RETRIEVED DURING THE PROCEDURE. THE PROCEDURE WAS ABLE TO BE COMPLETED ROBOTICALLY.

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 LYMPHADENECTOMY PROCEDURE, A SMALL PIECE OF THE UNIVERSAL CANNULA SEAL BROKE OFF INTO THE PATIENT. THE CUSTOMER WAS ABLE TO SUCCESSFULLY RETRIEVE THE PIECE DURING THE SAME SURGICAL PROCEDURE WHICH WAS COMPLETED AS PLANNED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A LITERATURE ARTICLE THAT EVALUATED THE PREOPERATIVE FINDINGS AND SURGICAL RESULTS OF THYMIC CYSTS SURGICALLY TREATED WITH ROBOTIC APPROACH WAS REVIEWED. THE STUDY INCLUDED 57 PATIENTS THAT UNDERWENT ROBOTIC SURGERY FOR THYMIC CYSTS IN THREE ITALIAN THORACIC SURGERY CENTERS BETWEEN MARCH 2014 AND APRIL 2022. SURGICAL PROCEDURES WERE ROBOTIC APPROACH IN ALL CASE INCLUDING 35 TOTAL/EXTENDED THYMECTOMY AND 22 CYST RESECTION/PARTIAL THYMECTOMY 22. IN ALL CASES, THE CYSTS WERE COMPLETELY REMOVED USING THE ROBOTIC APPROACH, WITH NO INSTANCES REQUIRING CONVERSION TO THORACOTOMY OR STERNOTOMY, AND NO INTRAOPERATIVE COMPLICATIONS WERE OBSERVED. THREE POSTOPERATIVE COMPLICATIONS WERE MENTIONED IN THE ARTICLE. ONE CASE REQUIRED REOPERATION FOR THORACIC DUCT CLOSURE DUE TO CHYLOTHORAX, ANOTHER CASE OF POSTOPERATIVE ANEMIA WAS MANAGED CONSERVATIVELY THROUGH BLOOD TRANSFUSION, AND A THIRD CASE OF POSTOPERATIVE RESPIRATORY FAILURE WAS EFFECTIVELY TREATED WITH NON-INVASIVE VENTILATION. THERE WERE NO POSTOPERATIVE MORTALITIES OBSERVED. THERE WERE NO DA VINCI DEVICE ISSUES REPORTED IN THE ARTICLE. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION FROM THE DESIGNATED AUTHOR WERE MADE, BUT NO RESPONSE HAS

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 THE MONARCH BRONCHOSCOPY PROCEDURE THE ARMS WERE STUCK IN STOW POSITION AND WILL NOT RESPOND. THE PHYSICIAN POWER CYCLED THE MONARCH SYSTEM A COUPLE OF TIMES AND RECONNECTED THE SYSTEM; HOWEVER, THERE WAS NO CHANGE. THE PHYSICIAN ELECTED TO ABORT THE CASE AND RESCHEDULE FOR A LATER DATE. THERE WAS NO REPORT OF AN ADVERSE EVENT DUE TO SYSTEM ISSUES.