Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2020, IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT WAS OBSERVED TO HAVE A PNEUMOTHORAX. THE TARGET LOCATION WAS RIGHT LOWER LOBE, BUT THE PNEUMOTHORAX WAS SEEN IN THE RIGHT UPPER LOBE, AND THE USER DID NOT DRIVE IN THE RIGHT UPPER LOBE. THE CAUSE OF THE PNEUMOTHORAX IS UNKNOWN. THE INSTRUMENTS USED WERE AN OLYMPUS NEEDLE AND AURIS FORCEPS. AN ENDOBRONCHIAL ULTRASOUND (EBUS) AND X-RAY WAS PERFORMED AFTER THE CASE. A CHEST TUBE WAS PLACED AND THE PATIENT WAS CHECKED INTO THE HOSPITAL. THE PNEUMOTHORAX WAS RESOLVED, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2020.

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 ON (B)(6) 2020, THE PATIENT WAS OBSERVED TO HAVE A PNEUMOTHORAX DURING POST-OP CHECK-UP. A CHEST TUBE WAS PLACED, AND THE PATIENT WAS HOSPITALIZED. THE PATIENT HAS SINCE RECOVERED AND WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2020. THERE WAS NO REPORT OF DEVICE FAILURE.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2020, IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT WAS OBSERVED TO HAVE A PNEUMOTHORAX. A CHEST TUBE WAS PLACED ON (B)(6) 2020 AND WAS REMOVED ON (B)(6) 2020. THE PATIENT WAS HOSPITALIZED FOR OBSERVATION AND PAIN MANAGEMENT. THE PATIENT HAS SINCE RECOVERED AND WAS RELEASED FROM HOSPITAL ON (B)(6) 2020.

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 ON (B)(6) 2020, THE PATIENT WAS OBSERVED TO HAVE A PNEUMOTHORAX DURING POST-OP CHECK-UP. A CHEST TUBE WAS PLACED TO TREAT THE PNEUMOTHORAX. THE PNEUMOTHORAX WAS RESOLVED, AND THE PATIENT WAS RELEASED ON (B)(6) 2020.

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 WAS OBSERVED TO HAVE A PNEUMOTHORAX DURING POST-OP CHECK-UP. THE LOCATION OF THE TARGET WAS LEFT LOWER LOBE. DURING THE CASE, THE INSTRUMENTS USED WERE SUPERD ASPIRATION NEEDLE, TRIPLE NEEDLE BRUSH AND SUPERTRAX FORCEPS. ENDOBRONCHIAL ULTRASOUND AND AN X-RAY WERE PERFORMED ON THE PATIENT. A CHEST TUBE WAS PLACED TO TREAT THE PNEUMOTHORAX, AND THE PATIENT WAS HELD OVERNIGHT. THE PATIENT HAS SINCE RECOVERED AND WAS RELEASED FROM HOSPITAL.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2020, IT WAS REPORTED THAT AFTER A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT WAS OBSERVED TO HAVE A PNEUMOTHORAX DURING POST-OP CHECK-UP. THE CUSTOMER DOES NOT FEEL THE PNEUMOTHORAX WAS CAUSED BY THE MONARCH PLATFORM. DURING THE CASE, NO AURIS INSTRUMENTS WERE USED. THE INSTRUMENT USED WAS A MEDTRONIC NEEDLE TIPPED CYTOLOGY BRUSH. A CHEST TUBE WAS PLACED TO TREAT THE PNEUMOTHORAX, AND THE PATIENT WAS HOSPITALIZED FOR 2 DAYS. THE PATIENT HAS SINCE RECOVERED AND WAS RELEASED FROM HOSPITAL.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2020, A PATIENT EXPERIENCED A PNEUMOTHORAX THAT WAS DISCOVERED THREE HOURS AFTER THE PROCEDURE DURING THE POST-OP CHECKS. THE PNEUMOTHORAX WAS LOCATED IN THE LEFT UPPER LUNG WHERE THE TARGET WAS LOCATED. DURING THE CASE, NO AURIS INSTRUMENTS WERE USED. THE INSTRUMENTS USED DURING THE CASE WERE AN OLYMPUS PERIVIEW 21 GAUGE NEEDLE, AND AN OLYMPUS FORCEPS. THE PATIENT WAS HELD OVERNIGHT FOR OBSERVATION, NO OTHER INTERVENTION WAS REQUIRED. THE PNEUMOTHORAX WAS RESOLVED, AND THE PATIENT WAS RELEASED ON THE FOLLOWING DAY.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A FEW DAYS AFTER A SUCCESSFUL BIOPSY PROCEDURE, A PNEUMOTHORAX IN THE RIGHT LOWER LOBE WAS DISCOVERED AND REPORTED BY THE PHYSICIAN ON (B)(6) 2020. A CHEST TUBE WAS PLACED TO RESOLVE THE PNEUMOTHORAX. THE PATIENT RECOVERED AND WAS RELEASED ON (B)(6) 2020.

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 CASE, THE PATIENT EXPERIENCE A PNEUMOTHORAX. THE PNEUMOTHORAX WAS LOCATED IN THE RIGHT UPPER LOBE. A CHEST TUBE WAS PLACED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS IN STABLE CONDITION AND WAS DISCHARGED FROM THE HOSPITAL AFTER THREE DAYS.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE CUSTOMER REPORTED A PNEUMOTHORAX ON (B)(6) 2020, AFTER THE THIRD CASE. IT WAS A SMALL RIGHT APICAL PNEUMOTHORAX. OLYMPUS NEEDLE AND AURIS FORCEPS WERE USED ALONG WITH FLUOROSCOPY. THE LOCATION OF THE TARGET WAS THE RIGHT UPPER LOBE. A SMALL PLEURAL CATHETER WAS USED AND LUNG WAS EXPANDED. NO FAULTS OCCURRED DURING THE TREATMENT AND PATIENT¿S CONDITION WAS STABLE. THE CASE WAS COMPLETED AND A MALIGNANT DIAGNOSIS CONFIRMED.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2020, PATIENT EXPERIENCED A PNEUMOTHORAX DURING THE POST PROCEDURE CHEST FLUOROSCOPY USING THE MONARCH SYSTEM. PATIENT WAS REQUIRED TO BE HOSPITALIZED. CHEST TUBE WAS PLACED ON (B)(6) 2020. PNEUMOTHORAX WAS RESOLVED AND PATIENT WAS RELEASED. ELEVEN SUCCESSFUL BIOPSIES WERE COMPLETED USING FIVE NON-AURIS NEEDLES, THREE NON-AURIS BRUSHES, AND THREE AURIS FORCEPS.