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 — 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.

Monarch Platform — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING BRONCHOSCOPY, THE PATIENT BECAME HYPOTENSIVE. THE CRITICAL CARE PULMONOLOGY TEAM WAS CALLED TO THE BEDSIDE. A CHEST TUBE WAS INSERTED AND AN IMMEDIATE GUSH OF AIR WAS OBSERVED. SHORTLY THEREAFTER THE PATIENT ARRESTED AND CPR WAS INITIATED. A LARGER-BORE CHEST TUBE WAS PLACED, RESULTING AGAIN IN A GUSH OF AIR. THE PATIENT WAS PRONOUNCED DEAD BY THE CRITICAL CARE TEAM. NECROTIC MATERIAL WAS EXPELLED DURING THE EVENT. A RAB (ROBOT-ASSISTED BRONCHOSCOPY) WITH 7-NEEDLE ASPIRATION WAS PERFORMED. THE DEATH WAS PRESUMED TO BE DUE TO A TENSION PNEUMOTHORAX. NO ISSUES WERE REPORTED WITH THE DEVICES USED DURING THE PROCEDURE.