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 ON (B)(6) 2019, A PATIENT HAD A PNEUMOTHORAX THAT WAS DISCOVERED AFTER A PROCEDURE. THE LOCATION OF THE LESION IS IN THE LEFT UPPER LOBE, AND A NEEDLE BIOPSY WAS PERFORMED USING A SUPER D ARCPOINT NEEDLE. THE LOCATION OF THE PNEUMOTHORAX IS IN THE LINGULAR OF THE LEFT LUNG. THERE WERE TWO PATHWAYS TAKEN TO ACCESS THE LESION, ONE FROM THE LEFT LOWER LOBE, AND ANOTHER FROM THE LEFT UPPER LOBE. A CHEST TUBE WAS PLACED IN THE PATIENT AND WAS ADMITTED TO THE HOSPITAL OVERNIGHT. 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: IT WAS REPORTED THAT ON (B)(6) 2019, A PATIENT HAD A PNEUMOTHORAX THAT WAS DISCOVERED THREE HOURS AFTER THE PROCEDURE WAS COMPLETED. THE PNEUMOTHORAX WAS LOCATED IN THE LEFT UPPER LOBE ALONG THE PLEURA SPACE. THERE WERE TWELVE NEEDLE PASSES PERFORMED, AND EIGHT TO TEN FORCEPS BITES WERE PERFORMED. A BRONCHOALVEOLAR LAVAGE (BAL) AND AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE WERE ALSO PERFORMED, THESE TARGETED TWO LEFT SIDED LYMPH NODES, THE MEDIASTINUM STATION 7 LYMPH NODE AND ONE RIGHT SIDED LYMPH NODE. PATIENT WAS HIGHLY EMPHYSEMIC AND HAD HIGH RISK POTENTIAL FOR COMPLICATIONS. A PIGTAIL TUBE WAS PLACED IN THE PATIENT AND PATIENT WAS ADMITTED TO THE HOSPITAL OVERNIGHT. 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) 2019, THE CUSTOMER REPORTED THAT A PATIENT HAD A PNEUMOTHORAX. THE PNEUMOTHORAX WAS FOUND AND REPORTED AFTER THE PROCEDURE WHILE THE PATIENT WAS IN POST ANESTHESIA CARE FOLLOW-UP. THE PLAN HAD TWO TARGETS, ONE IN RIGHT UPPER LUNG (RUL) AND ONE IN LEFT LOWER LUNG (LLL). THE LOCATION OF THE PNEUMOTHORAX WAS IN THE RUL. THE PHYSICIAN USED AN AURIS CYTOLOGY BRUSH, AN AURIS BIOPSY FORCEPS, AND A COOK EUS 22GAUGE NEEDLE (AKA ECHO TIP). AT THIS TIME, THE PHYSICIAN DOES NOT ATTRIBUTE THE PNEUMOTHORAX WAS CAUSED BY ANY AURIS INSTRUMENT OR DEVICE. A FOLLOW-UP WITH THE ACCOUNT MANAGER FOR THE SITE CONFIRMED THAT A CHEST TUBE WAS PLACED IN THE PATIENT WHO RECOVERED AND WAS RELEASED ON THE FOLLOWING DAY. BASED ON THE INFORMATION PROVIDED BY THE PHYSICIAN, THERE WAS NO 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 10/10/2019, IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BIOPSY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET WAS IN LEFT UPPER LOBE (LUL) APICAL POSTERIOR SEGMENT NEAR THE PLEURA. THE INSTRUMENTS USED WERE AURIS BRONCHOSCOPE, REBUS PROBE AND SUPERD ARC POINT NEEDLE. THE PHYSICIAN TOOK BIOPSIES USING SUPERD ARC POINT NEEDLE. IT WAS REPORTED THAT AFTER SUCCESSFUL FIRST AND SECOND PASSES, THE PHYSICIAN OBSERVED PNEUMOTHORAX ON THE THIRD PASS. AFTER COMPLETING THE PROCEDURE, A CHEST TUBE WAS PLACED IN THE PATIENT. THE CUSTOMER CONFIRMED ON (B)(6) 2019 THAT PNEUMOTHORAX WAS RESOLVED AFTER CHEST TUBE PLACEMENT AND THE PATIENT WAS DISCHARGED.

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) 2019, IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BIOPSY PROCEDURE, THE PATIENT HAD A PNEUMOTHORAX. THE PHYSICIAN PERFORMED SEVERAL BIOPSIES IN THE LOWER UPPER LUNG (LUL) AND SEVERAL BIOPSIES IN THE RIGHT UPPER LUNG (RUL). THE PHYSICIAN THEN PERFORMED AN ENDOBRONCHIAL ULTRASOUND (EBUS) ON THE RIGHT SIDE OF THE PATIENT'S LUNG AND COMPLETED THE PROCEDURE. THE PNEUMOTHORAX WAS THEN DISCOVERED ABOUT AN HOUR AFTER THE CASE DURING A POST-PROCEDURE X-RAY. THE PATIENT WAS THEN GIVEN A CHEST TUBE AND WAS HELD AT THE HOSPITAL. THE PATIENT RECOVERED AND WAS RELEASED FROM THE HOSPITAL ON THE FOLLOWING DAY. BASED ON THE INFORMATION PROVIDED BY THE PHYSICIAN, THERE WAS NO 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 9/23/2019, IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BIOPSY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE PNEUMOTHORAX WAS NOTED TO BE IN THE SAME AREA AS THE TARGET LESION. THE CUSTOMER CONFIRMED THAT THE CUSTOMER RECEIVED A CHEST TUBE AND SHORTLY RECOVERED AND WAS RELEASED. BASED ON THE INFORMATION PROVIDED BY THE PHYSICIAN, THERE WAS NO DEVICE FAILURE. IT WAS THE CUSTOMER'S BELIEF THAT THE PNEUMOTHORAX COULD BE ATTRIBUTED TO THE BIOPSY THAT WAS PERFORMED WITH NON-AURIS INSTRUMENTS.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 9/20/2019, IT WAS REPORTED THAT AFTER A MONARCH- ASSISTED BIOPSY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE LOCATION OF THE PNEUMOTHORAX WAS UNKNOWN. THE LESION WAS LOCATED IN THE RIGHT UPPER LOBE. THE PHYSICIAN DROVE TO THE LESION AND COLLECTED A BIOPSY USING A SUPERD ARCPOINT NEEDLE, SUPERD TRIPLE NEEDLE BRUSH AND AURIS FORCEPS. THE PNEUMOTHORAX WAS UNKNOWN UNTIL AFTER THE CASE WAS COMPLETED. ON (B)(6) 2019,FOLLOW UP WITH THE CUSTOMER CONFIRMED THAT THE PATIENT RECEIVED A CHEST TUBE, THE PATIENT RECOVERED FROM THE PNEUMOTHORAX, AND WAS RELEASED.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 9/19/19, IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BIOPSY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE CASE INVOLVED TWO TARGETS, ONE IN THE RIGHT LOWER LOBE AND ONE IN THE RIGHT UPPER LOBE. THE PHYSICIAN FIRST NAVIGATED THE BRONCHOSCOPE TO THE FIRST TARGET, WHICH WAS IN THE RIGHT LOWER LOBE AND COLLECTED BIOPSIES USING AN OLYMPUS PERRY FLEX NEEDLE AND AURIS BIOPSY FORCEPS. AFTER ACQUIRING THE SAMPLE FROM THE TARGET IN THE RIGHT LOWER LOBE, THE PHYSICIAN THEN PROCEEDED TO NAVIGATE THE BRONCHOSCOPE TO THE TARGET IN THE RIGHT UPPER LOBE. WHILE NAVIGATING IN THE RIGHT UPPER LOBE, THE PHYSICIAN OBSERVED THE PNEUMOTHORAX IN THE APEX OF THE LUNG. ON (B)(6) 2019, FOLLOW UP WITH THE CUSTOMER CONFIRMED THAT THE PATIENT RECEIVED A CHEST TUBE, RECOVERED FROM THE PNEUMOTHORAX, AND WAS RELEASED TWO DAYS AFTER. BASED ON FOLLOW-UP WITH THE CUSTOMER , THAT THERE WAS NO DEVICE FAILURE.

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-ASSISTED BIOPSY PROCEDURE, THE IRRIGATION PUMP WOULD NOT RESPOND TO COMMANDS FROM THE CONTROLLER AFTER THE CONTROLLER HAD BEEN DROPPED. THE SYSTEM WAS SHUT DOWN TO STOP THE IRRIGATION PUMP. APPROXIMATELY 500 ML OF SALINE WAS IRRIGATED INTO THE LUNG. THE PHYSICIAN USED A NON-AURIS MANUAL SCOPE TO REMOVE THE EXTRA FLUID. THE PHYSICIAN REPORTED THAT THE PATIENT CLEARED A SHORT OBSERVATION AND RECOVERED WITHOUT ANY PROBLEMS. 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 INFORMATION WAS RECEIVED DURING A PHONE CALL WITH THE PHYSICIAN ON 10/30/2019: ON (B)(6) 2019, THE PATIENT UNDERWENT A MONARCH-ASSISTED BIOPSY PROCEDURE. A FEW DAYS AFTER THE PROCEDURE, ON (B)(6) 2019, THE PATIENT INFORMED THE PHYSICIAN THAT THEY WERE EXPERIENCING CHEST PAINS. A CHEST X-RAY WAS TAKEN, AND A PNEUMOTHORAX WAS IDENTIFIED. THE HOSPITAL PLACED A CHEST TUBE IN THE PATIENT AND THE PATIENT WAS HELD OVERNIGHT. THE PATIENT RECOVERED AND WAS RELEASED THE NEXT DAY. THERE WAS NO ALLEGATION 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: IT WAS REPORTED THAT AT THE END OF THE PROCEDURE, THE PHYSICIAN NOTICED A TEAR ON THE RIGHT SIDE OF THE TRACHEA AT THE DISTAL END. THE PATIENT WAS SENT TO ANOTHER DEPARTMENT TO HAVE A STENT PLACED TO TREAT THE TEAR. NO DEVICE MALFUNCTION WAS 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 APPROXIMATELY TWO (2) HOURS AFTER A SUCCESSFUL MONARCH-ASSISTED BIOPSY PROCEDURE, A PNEUMOTHORAX WAS IDENTIFIED WHILE THE PATIENT WAS STILL IN THE HOSPITAL, AND A CHEST TUBE WAS PLACED. THE PATIENT WAS DISCHARGED THE NEXT DAY. THERE WERE NO REPORTED ISSUES WITH THE MONARCH SYSTEM. THE PHYSICIAN STATED THAT THE CAUSE OF PNEUMOTHORAX WAS THE ANATOMY OF THE PATIENT'S NODULE AND THE SEVERITY OF THEIR LUNG DISEASE. THE PHYSICIAN ALSO STATED THAT THE PNEUMOTHORAX WAS NOT CAUSED BY THE MONARCH PLATFORM. PNEUMOTHORAX IS A KNOWN POTENTIAL RISK OF PERIPHERAL LUNG BIOPSY.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PATIENT UNDERWENT MONARCH BRONCHOSCOPY PROCEDURE WITH BIOPSY UNDER CLINICAL PROTOCOL AND AURIS BECAME AWARE OF AN EVENT FROM CLINICAL CASE REPORT FORM THAT ON (B)(6) 2019 A PNEUMOTHORAX WAS IDENTIFIED IN A PATIENT FOLLOWING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019 USING THE MONARCH ENDOSCOPY PLATFORM (MONARCH PLATFORM). ACCORDING TO THE REPORT, A SIX-MILLIMETER PNEUMOTHORAX WAS OBSERVED IN A POST PROCEDURE X-RAY APPROXIMATELY 2 HOURS POST BRONCHOSCOPY PROCEDURE. THE X-RAY WAS REPEATED APPROXIMATELY 3 HOURS POST PROCEDURE AND THE PATIENT WAS DEEMED STABLE AND DISCHARGED FROM THE HOSPITAL. THE PATIENT REPORTED A MILD SORE THROAT AND CHEST PAIN BUT OTHERWISE FELT FINE IN A 24-HOUR FOLLOW-UP PHONE CALL. TWO (2) DAYS AFTER THE PROCEDURE ((B)(6) 2019), AN URGENT CARE PHYSICIAN CONTACTED THE HOSPITAL WHERE THE PROCEDURE WAS PERFORMED TO REPORT THAT AN X-RAY INDICATED A 25% COLLAPSE OF THE PATIENT'S RIGHT LUNG. A FELLOW ADVISED SENDING THE PATIENT TO HOSPITAL TO BE MONITORED WITH REPEAT X-RAY IN MORNING. ON (B)(6) 2019 A FELLOW RECEIVED A CALL FROM PHYSICIAN AT THE HOSPITAL INDICATING THAT THE PATIENT'S PNEUMOTHORAX MEASURED 13 MM AND CHEST CT DEMONSTRATED HYDROPNEUMOTHORAX AT TIM

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 A PATIENT SUFFERED A PNEUMOTHORAX DURING OR AFTER THE PROCEDURE. THE PATIENT WAS ADMITTED AND A CHEST TUBE WAS PLACED. THE PNEUMOTHORAX RESOLVED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITH NO RESIDUAL EFFECTS. NO DEVICE MALFUNCTION WAS REPORTED.