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: 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 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.

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. A VALVE WAS PLACED AND PATIENT WAS HOSPITALIZED. 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 AFTER A SUCCESSFUL ROBOTIC BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. A CHEST TUBE WAS PLACED. NO SYSTEM 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 ROBOTIC BRONCHOSCOPY PROCEDURE THE PHYSICIAN HAD DIFFICULTY WITH THE PATIENT SENSORS 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 THE MONARCH BRONCHOSCOPY PROCEDURE, THE PHYSICIAN WAS PERFORMING THE BRONCHOALVEOLAR LAVAGE (BAL) WHEN THE PATIENT HAD A CARDIAC ARREST. THE PHYSICIAN WAS ABLE TO CONFIRM A PULSE BACK ON THE PATIENT. THE PATIENT IS IN STABLE CONDITION.

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 USED EBUS TO TARGET THE RIGHT UPPER LOBE (RUL). THE PHYSICIAN NOTICED THROUGH HIS MANUAL SCOPE THAT THERE WAS A SMALL LACERATION ON THE MUCOSA OF THE POST INTERIOR WALL OF THE RIGHT MAIN STEM. THE PHYSICIAN WAS NOT SURE HOW THIS OCCURRED. THE PHYSICIAN DECIDED TO ABORT THE CASE BECAUSE THEY DID NOT WANT TO CAUSE ANY FURTHER INJURY. THE PATIENT DID NOT EXPERIENCE ANY BLEEDING UPON WAKING UP. NOTABLY, THE ANESTHESIOLOGIST SUGGESTED THAT THE PATIENT MAY HAVE HAD FRAIL TISSUE, AND THE PHYSICIAN RECALLED A SIMILAR INCIDENT FROM TWO YEARS PRIOR IN THE SAME LOCATION, WHICH HAD RESOLVED WITHOUT COMPLICATIONS.

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 DIFFICULTY NAVIGATING 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 THE BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED MEDIASTINAL EMPHYSEMA, AS INDICATED BY THE POSTOPERATIVE CT EXAMINATION. AFTER A FOLLOW-UP CT SCAN DEMONSTRATED RECOVERY, THE PATIENT WAS DISCHARGED ON (B)(6), FOLLOWING A TOTAL HOSPITAL STAY OF 6 DAYS.

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 ROBOTIC BRONCHOSCOPY PROCEDURE, THE PATIENT HAD A PNEUMOTHORAX. A CHEST TUBE WAS PLACED AND THE PATIENT WAS MONITORED. THE PNEUMOTHORAX RESOLVED AND THE PATIENT WAS DISCHARGED HOME SIX DAYS AFTER 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 (VIA MEDSUN UF/IMPORTER REPORT # (B)(4)) THAT AFTER THE MONARCH BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX.

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 PROCEDURE THE PHYSICIAN WAS UNABLE TO TURN THE BRONCHOSCOPE ON AFTER REMOVING THE SCOPE FROM THE PATIENT'S TRACHEA DUE TO THE CAMERA IMAGE BEING GRAINY AND ULTIMATELY GOING BLACK. 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 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 WAS UNABLE TO QUERY PACS (PICTURE ARCHIVING AND COMMUNICATION SYSTEM) AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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 THE PATIENT CODED DURING PROCEDURE, THE PHYSICIAN HAD CONDUCTED 4-BIOPSIES AND ON THE 5TH BIOPSY AN ABNORMAL AMOUNT OF BLOOD WAS COMING THROUGH THE ET TUBE. THE SCOPE AND THE PATIENT INTRODUCER WERE REMOVED AND THEY WERE ABLE TO STABILIZE THE PATIENT IN THE ROOM. THE PATIENT WAS MOVED TO ICU WHERE THEY LATER CODED AND PASSED AWAY. THE PHYSICIAN STATED THAT THE MONARCH DID NOT CAUSE OR CONTRIBUTE TO THE DEATH.