Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: During a robot-assisted bronchoscopy, anesthesia noted ST-segment elevation after approximately six needle biopsy passes. The procedure was paused, and evaluation for pneumothorax was negative. An EKG assessment was initiated but temporarily interrupted by a building power outage. The patient was transferred to the Cath Lab, evaluated, and cleared. The patient had a history of cardiac issues and stent placement approximately eight months earlier. No device issues were reported. The procedure was aborted, and the patient was discharged home on (b)(6) 2026.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: During a robot-assisted bronchoscopy procedure, bleeding occurred and was controlled within minutes using cold saline and a balloon blocker. The patient remained stable, the procedure was aborted, and the patient was discharged home later that day ((b)(6)2026).

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING ARTICLE HAS BEEN REVIEWED: DIAGNOSTIC OUTCOMES OF ROBOTIC BRONCHOSCOPY IN A MULTIDISCIPLINARY, MULTI-HOSPITAL LUNG NODULE PROGRAM. RACHEL L. DEITZ, ¿, RYAN M. LEVY. DEPARTMENT OF CARDIOTHORACIC SURGERY, UNIVERSITY OF PITTSBURGH MEDICAL CENTER, PITTSBURGH, PENNSYLVANIA, J SURG RES. VOLUME 324 P210-220. 2026. THE AIM OF OUR STUDY WAS TO ASSESS THE DIAGNOSTIC ACCURACY OF ROBOTIC BRONCHOSCOPY ACROSS MULTIPLE USERS IN MULTIPLE HOSPITALS WITHIN A SINGLE HEALTH SYSTEM WITH THE LARGEST PATIENT COHORT IN THE LITERATURE TO DATE. THIS REPORT IS BEING SUBMITTED FOR THE FOLLOWING REPORTED COMPLICATIONS: POSTOPERATIVE RESPIRATORY FAILURE: - 8 PATIENTS (0.8%). NEW HOME OXYGEN EVALUATION AND THERAPY COORDINATION: - 7 PATIENTS (0.7%). ENDOBRONCHIAL BLEEDING WITH PROLONGED INTUBATION: - 3 PATIENTS (0.3%); EXTUBATED THE NEXT DAY AFTER TOILET BRONCHOSCOPY. PNEUMOTHORAX: 51 PATIENTS (5.0%); MOST COMMON COMPLICATION. TUBE THORACOSTOMY WAS REQUIRED IN 33 PATIENTS (3.0%). NO TEMPORAL ASSOCIATION WAS OBSERVED. PATIENT FACTORS, INCLUDING COPD OR PRIOR CHEST SURGERY, WERE NOT ASSOCIATED WITH INCREASED TUBE THORACOSTOMY RISK. RADIAL EBUS USE WAS ASSOCIATED WITH LOWER SIGNIFICANT PNEUMOTHORAX RIS

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PRIOR TO THE PROCEDURE, DURING PATIENT INTUBATION, THE PATIENT ASPIRATED AND VOMITED. THE ANESTHESIOLOGIST CLEARED THE PATIENT¿S LUNGS, AND THE CASE PROCEEDED. DURING THE PROCEDURE, BLEEDING OCCURRED, RESULTING IN LOSS OF CLEAR VISUALIZATION. THE PATIENT¿S BLOOD PRESSURE INCREASED, AND THE PHYSICIAN ELECTED TO ABORT THE PROCEDURE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND WAS DISCHARGED HOME THE SAME DAY.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A MONARCH BRONCHOSCOPY PROCEDURE, THE PHYSICIAN ENCOUNTERED SYSTEM ERRORS AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A MONARCH BRONCHOSCOPY PROCEDURE, THE PHYSICIAN EXPERIENCED A SYSTEM ISSUE AND ELECTED TO ABORT THE CASE. NO CLINICAL CONSEQUENCES FOR THE PATIENT WERE REPORTED.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING ARTICLE HAS BEEN REVIEWED: TITLE: MULTICENTER BRONCHOSCOPIC ASSESSMENT OF MULTIFOCAL PERIPHERAL PULMONARY NODULES: THE MULTIBRANCH STUDY FREE R BHARGAVA DOI: HTTPS://DOI.ORG/10.1093/AJRCCM/AAMAG162.3392. THE AIM OF THIS STUDY IS TO PRESENT THE PROCEDURAL CHARACTERISTICS, SAFETY, DIAGNOSTIC YIELD, AND USE OF LINEAR ENDOBRONCHIAL ULTRASOUND (EBUS) STAGING IN PATIENTS WITH MULTIFOCAL PULMONARY NODULES BIOPSIED UNDER A SINGLE ANESTHESIA EVENT. BETWEEN 11/2019 - 8/2025, A TOTAL OF 191 PATIENTS UNDERGOING RAB BIOPSY OF MULTIFOCAL PERIPHERAL PULMONARY LESIONS AND LYMPH NODE ASSESSMENT USING MONARCH SYSTEMS. THIS REPORT IS BEING SUBMITTED FOR THE FOLLOWING REPORTED COMPLICATIONS: REPORTED COMPLICATIONS ARE N=14; PNEUMOTHORAX TREATMENT: 4 PATIENTS REQUIRING TUBE THORACOSTOMY N=3; TRANSIENT HYPOXIA. TREATMENT: NOT MENTIONED. N=3; OUTPATIENT-MANAGED BRONCHITIS TREATMENT: NOT MENTIONED. N=7; UNSPECIFIED COMPLICATIONS TREATMENT: REQUIRED UNPLANNED ADMISSION.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING ARTICLE HAS BEEN REVIEWED: TITLE: DIAGNOSTIC YIELD AND COMPLICATION RATES IN HIGH-RISK PATIENTS UNDERGOING ROBOTIC BRONCHOSCOPY FOR WORKUP OF LUNG NODULES AUTHORS: A. DUGO, T. P. DALY, M. LIN, M. A. DIRICO, D. MANCHESTER, D. CORWIN, D. M. STAHLNECKER DOI: NOT PROVIDED (NO PUBMED CITATION AVAILABLE)THE AIM OF THIS STUDY IS TO EVALUATE DIAGNOSTIC YIELD AND COMPLICATION RATES FOR USE OF ROBOTIC BRONCHOSCOPY FOR LUNG NODULE SAMPLING IN HIGH-RISK PATIENTS. A TOTAL OF 198 PATIENTS WHO UNDERWENT ROBOTIC BRONCHOSCOPY FOR SAMPLING OF LUNG NODULES USING THE MONARCHTM ROBOT. REPORTED COMPLICATIONS ARE N=5; BLEEDING TREATMENT: NOT MENTIONED. N=1; CHF (CONGESTIVE HEART FAILURE) EXACERBATION TREATMENT: NOT MENTIONED. N=1; OTHER COMPLICATION TREATMENT: NOT MENTIONED. N=12; PNEUMOTHORAX TREATMENT: NOT MENTIONED.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING ARTICLE HAS BEEN REVIEWED: TITLE: ROBOT-ASSISTED BRONCHOSCOPY FOR LUNG NODULE DIAGNOSIS: A PILOT FEASIBILITY STUDY AUTHORS: U. CHADDHA, S. P. KOVACS, C. MANLEY, M. SHENDE, S. MURGU, D. K. HOGARTH DOI: NOT PROVIDED. THE AIM OF THIS STUDY IS TO EVALUATE THE FEASIBILITY OF PERFORMING RAB IN CONSECUTIVE PATIENTS WITH LUNG NODULES REFERRED FOR BRONCHOSCOPIC BIOPSY. BETWEEN (B)(6) 2018, A TOTAL OF 82 PATIENTS UNDERWENT RAB PROCEDURES WITH THE MONARCH PLATFORM (AURIS SURGICAL ROBOTICS, (B)(6) CA). THIS REPORT IS BEING SUBMITTED FOR THE FOLLOWING REPORTED COMPLICATIONS ARE: N=4.8%; PNEUMOTHORAX TREATMENT: NOT MENTIONED N= 3.7%; SIGNIFICANT BLEEDING TREATMENT: NOT MENTIONED N=69.5%; BRONCHUS SIGN (INCLUDING LESIONS WITH AN AIRWAY GOING TO THE NODULE EDGE) TREATMENT: NOT MENTIONED N=1; CASE WAS ABORTED.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING ARTICLE HAS BEEN REVIEWED: TITLE: MULTICENTER, PROSPECTIVE PILOT AND FEASIBILITY STUDY OF ROBOTIC-ASSISTED BRONCHOSCOPY FOR PERIPHERAL PULMONARY LESIONS. AUTHORS: NICHOLAS PASTIS AMIT MAHAJAN SANDEEP KHANDHAR MICHAEL SIMOFF MICHAEL MACHUZAK JOSEPH CICENIA THOMAS GILDEA AND GERARD SILVESTRI CITATION: NOT PROVIDED DOI: HTPS://DOI.ORG/10.1016/J.CHEST.2019.08.313 AND CITED ONE (1) INSTANCE OF PNEUMOTHORAX WITH INTERVENTION. THIS REPORT IS BEING SUBMITTED FOR THESE EVENTS.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING ARTICLE HAS BEEN REVIEWED: COMPARISON OF DIAGNOSTIC YIELD: ACCURACY AND SAFETY OF ION VS MONARCH ROBOTIC BRONCHOSCOPY PLATFORMS. AUTHORS: ALISHA SHARMA DANAI KHEMASUWAN ARNALDO A RODRIGUEZ-RIVERA JAASRINI REDDY VELLORE HOPE KRAMER JOSHUA BORON TORIBIONG UCHEL AND RAY W SHEPHERD DOI: HTTPS://DOI.ORG/10.1016/J.CHEST.2025.07.3308 AND CITED SIX (6) INSTANCES OF PNEUMOTHORAX WITH INTERVENTION. THIS REPORT IS BEING SUBMITTED FOR THESE EVENTS.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING ARTICLE HAS BEEN REVIEWED: PATEL P, OST DE, SHALLER B, CHANG J, YENEPALLI A, CHOI HJ, FREE D, KANG CY, SUMNER E, CAO C, BEDI H, CONE BEAM COMPUTED TOMOGRAPHY-GUIDED BRONCHOSCOPY VERSUS COMPUTED TOMOGRAPHY-GUIDED TRANSTHORACIC NEEDLE BIOPSY FOR PERIPHERAL PULMONARY LESION DIAGNOSIS, CHEST (2026), DOI: HTTPS://DOI.ORG/10.1016/J.CHEST.2026.02.038 AND CITED SEVEN (7) INSTANCES OF SERIOUS EVENTS AND TWO (2) PNEUMOTHORAX WITH INTERVENTION. THIS REPORT IS BEING SUBMITTED FOR THESE EVENTS.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: FOLLOWING COMPLETION OF THE ROBOTIC-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. THE PATIENT WAS HOSPITALIZED AND A CHEST TUBE WAS PLACED. THE PNEUMOTHORAX RESOLVED, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2026. NO DEVICE-RELATED ISSUES WERE REPORTED.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING THE PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A CHEST TUBE WAS PLACED, AND THE PATIENT REMAINED STABLE. NO DEVICE-RELATED ISSUES WERE REPORTED.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A ROBOTICALLY ASSISTED BRONCHOSCOPY PROCEDURE TARGETING A RIGHT UPPER LOBE NODULE, AS THE PHYSICIAN ADVANCED THE RADIAL PROBE IT WAS NOTICED THAT THE PATIENT TURNED PURPLE. THE TEAM IMMEDIATELY ABORTED THE PROCEDURE AND REMOVED THE BRONCHOSCOPE AND RADIAL PROBE. THE PATIENT CODED BUT WAS REVIVED AND TRANSFERRED TO THE MEDICAL INTENSIVE CARE UNIT (MICU). PATIENT IS STABLE AND DISCHARGED FROM HOSPITAL ON (B)(6) 2026. NO BIOPSIES WERE TAKEN, AND THERE WERE NO REPORTED ISSUES WITH THE DEVICES. THE PHYSICIAN ATTRIBUTED THE EVENT TO ANESTHESIA AND THE PATIENT¿S UNDERLYING HEALTH ISSUE.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A MONARCH BRONCHOSCOPY PROCEDURE, BLEEDING OCCURRED FOLLOWING WITHDRAWAL OF THE SCOPE AND INSERTION OF A CRYOPROBE. BIOPSY WAS SUCCESSFULLY OBTAINED AND THE PROCEDURE WAS COMPLETED. NO DEVICE-RELATED ISSUES WERE IDENTIFIED. THE PATIENT WAS TRANSFERRED TO THE ICU FOR MONITORING AND DISCHARGED ON (B)(6) 2026.

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 BRONCHOSCOPY PROCEDURE THE TEAM STRUCK THE PATIENT'S AORTA WHILE PERFORMING A BIOPSY WITH AN OLYMPUS PREVIEW NEEDLE. COLD SALINE WAS INJECTED AND THE CASE WAS ABORTED. THE PATIENT WAS HOSPITALIZED AND DISCHARGED THE NEXT DAY, (B)(6) 2026. NO DEVICE-RELATED ISSUES WERE REPORTED.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER SUCCESSFUL MONARCH BRONCHOSCOPY, THE PATIENT DEVELOPED A PNEUMOTHORAX REQUIRING HOSPITALIZATION AND WAS DISCHARGED ON (B)(6) 2026. NO DEVICE-RELATED ISSUES WERE IDENTIFIED.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER FOLLOWING A SUCCESSFUL MONARCH BRONCHOSCOPY, THE PATIENT DEVELOPED A PNEUMOTHORAX AND WAS SUBSEQUENTLY HOSPITALIZED AND RELEASED ON (B)(6) 2026. NO DEVICE-RELATED ISSUES WERE REPORTED.

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 BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. PATIENT WAS HOSPITALIZED AND CHEST TUBE WAS PLACED. THE PNEUMOTHORAX RESOLVED AND THE PATIENT WAS RELEASED . NO DEVICE ISSUES WERE REPORTED.

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 BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. PATIENT WAS HOSPITALIZED AND CHEST TUBE WAS PLACED. THE PNEUMOTHORAX RESOLVED AND THE PATIENT WAS RELEASED ON (B)(6) 2026. NO DEVICE ISSUES WERE REPORTED.

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 BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX THAT REQUIRED CHEST TUBE. NO DEVICE ISSUES WERE REPORTED.

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 BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. PATIENT WAS HOSPITALIZED AND PIGTAIL CATHETER WAS PLACED. THE PNEUMOTHORAX RESOLVED AND THE PATIENT WAS RELEASED ON (B)(6) 2026. NO DEVICE ISSUES WERE REPORTED.

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 BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX THAT REQUIRED CHEST TUBE. NO DEVICE ISSUES WERE REPORTED.

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 BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. PATIENT WAS HOSPITALIZED AND CHEST TUBE WAS PLACED. THE PNEUMOTHORAX RESOLVED AND THE PATIENT WAS RELEASED ON (B)(6) 2026. NO DEVICE ISSUES WERE REPORTED.

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 BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED A SCOPE ISSUE AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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 BRONCHOSCOPY PROCEDURE, THE PHYSICIAN ENCOUNTERED SYSTEM ISSUES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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 BRONCHOSCOPY PROCEDURE, THE PHYSICIAN ENCOUNTERED NAVIGATION ISSUES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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 BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED A SYSTEM ISSUES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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 BRONCHOSCOPY PROCEDURE THE PHYSICIAN OBSERVED BLEEDING. THE CASE WAS COMPLETED; THE BLEEDING OCCURRED IN ASSOCIATION WITH A CRYOBIOPSY, AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT WAS SUBSEQUENTLY DISCHARGED FROM THE HOSPITAL AND A DIAGNOSIS WAS ESTABLISHED. THE PHYSICIAN DID NOT ATTRIBUTE THIS EVENT TO THE MONARCH SYSTEM.

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 BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. PATIENT WAS HOSPITALIZED AND CHEST TUBE WAS PLACED. THE PNEUMOTHORAX RESOLVED AND THE PATIENT WAS RELEASED ON (B)(6) 2026. NO DEVICE ISSUES WERE REPORTED.

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 BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. PATIENT WAS HOSPITALIZED AND CHEST TUBE WAS PLACED. THE PATIENT WAS RELEASED ON (B)(6) 2025. NO DEVICE ISSUES WERE REPORTED.

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 BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED A SCOPE ISSUE AND DID NOT HAVE ANY ADDITIONAL SCOPES TO CONTINUE THE PROCEDURE. THE PHYSICIAN ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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 BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED A SCOPE ISSUE AND DID NOT USE ANY ADDITIONAL SCOPES TO CONTINUE THE PROCEDURE. THE PHYSICIAN ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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 BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. PATIENT WAS HOSPITALIZED AND CHEST TUBE WAS PLACED. THE PNEUMOTHORAX RESOLVED AND THE PATIENT WAS RELEASED ON (B)(6) 2025. NO DEVICE ISSUES WERE REPORTED.

Monarch Platform — Death 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 ROBOTICALLY ASSISTED BRONCHOSCOPY PROCEDURE, AS THE PHYSICIAN WAS TAKING ANTERIOR/POSTERIOR SCOUT SHOTS USING A 3D C-ARM, THE PATIENT BEGAN TO EXHIBIT IRREGULAR HEART RHYTHMS. THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE. THE PATIENT WENT INTO ATRIAL FIBRILLATION AND CODED. CHEST COMPRESSIONS WERE STARTED IMMEDIATELY. THE CODE CONTINUED FOR 30 - 35 MINUTES, AND THE PATIENT PASSED AWAY. NO BIOPSIES OR NEEDLE ASPIRATIONS WERE PERFORMED DURING THE PROCEDURE. NO ISSUES WERE REPORTED INVOLVING THE DEVICES USED DURING THE PROCEDURE.

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 BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED SYSTEM FAULT MESSAGES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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 SUCCESSFUL ROBOTIC BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. PATIENT WAS HOSPITALIZED AND CHEST TUBE WAS PLACED. NO DEVICE ISSUES WERE REPORTED.

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 BRONCHOSCOPY PROCEDURE, THE PHYSICIAN ENCOUNTERED NAVIGATION ISSUES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING ARTICLE HAS BEEN REVIEWED: MCNIERNEY D, CHEN J, ZEIN JG, VASZAR L, SWANSON K, AZADEH N, SAKATA KK. COMPARING MONARCH VERSUS ION ROBOTIC-ASSISTED BRONCHOSCOPY PLATFORMS: A PROPENSITY SCORE-MATCHED ANALYSIS. J BRONCHOLOGY INTERV PULMONOL. 2025 JUL 15;32(4):E01019. DOI: 10.1097/LBR.0000000000001019. PMID: 40662912, AND CITED FOUR (4) INSTANCES OF PNEUMOTHORAX WITH CHEST TUBE PLACEMENT. THIS REPORT IS BEING SUBMITTED FOR THESE EVENTS.

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 BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED SYSTEM FAULT MESSAGES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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 BRONCHOSCOPY PROCEDURE, THE PHYSICIAN ENCOUNTERED NAVIGATION ISSUES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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 BRONCHOSCOPY PROCEDURE, THE PHYSICIAN ENCOUNTERED CART BOOT UP ISSUE AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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 THE PHYSICIAN STARTED THE CASE WITH ENDOBRONCHIAL ULTRASOUND (EBUS) AND THEN SWITCHED TO MONARCH. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED SYSTEM FAULT MESSAGES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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 BRONCHOSCOPY PROCEDURE, THE PHYSICIAN ENCOUNTERED NAVIGATION ISSUES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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 BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED SYSTEM FAULT MESSAGES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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 BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED NAVIGATION ACCURACY ISSUES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT..

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING MULTIPLE PROCEDURES, THE MONARCH ROBOT NAVIGATION SYSTEM WAS UNSURE WHICH AREA OF THE LUNG IT WAS IN WITH DISTANCE MEASUREMENTS VARYING UP TO 30MM. BIOMED WAS ABLE TO RECREATE PRODUCT ISSUE IN DEMO ENVIRONMENT. PROBLEMS INTERMITTENTLY BEGAN AFTER SOFTWARE UPDATE 5 WEEKS AGO BUT BECAME MORE CONSISTENT LAST WEEK.

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 BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED SYSTEM FAULT MESSAGES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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 BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED SYSTEM FAULT MESSAGES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.