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, PATIENT EXPERIENCED A PNEUMOTHORAX. THE PNEUMOTHORAX WAS DISCOVERED DURING POST-OP CHECK VIA A CHEST X-RAY. THE LOCATION OF THE TARGET AND PNEUMOTHORAX WAS LEFT LOWER LOBE. THE PNEUMOTHORAX WAS A 30-40%. A CHEST TUBE WAS PLACED AND THE PATIENT WAS RELEASED 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: IT WAS REPORTED THAT A PATIENT WITH A HISTORY OF LUPUS AND A RECENT BRONCHOSCOPY FOR A BIOPSY OF THE LEFT LUNG NODULE RETURNED TO THE HOSPITAL THE FOLLOWING MORNING FOR PAIN IN THE LEFT CHEST AND REQUESTED A CHEST X-RAY FOR FURTHER EVALUATION. THE PATIENT DENIES SHORTNESS OF BREATH BUT REPORTS INCREASED PAIN WITH DEEP BREATHING. THE PATIENT DID HAVE A POST PROCEDURE X-RAY DONE FOLLOWING THE PROCEDURE WHICH SHOWED NO PNEUMOTHORAX. THE PATIENTS PAIN STARTED ON THE WAY HOME FROM THE PROCEDURE THE PREVIOUS DAY. A THORA VENT WAS PLACED INTO THE LEFT CHEST. SUCTIONING WAS USED FOR ABOUT AN HOUR. A REPEAT X-RAY AT THAT TIME SHOWED NEAR COMPLETE RESOLUTION OF THE PNEUMOTHORAX ON THE LEFT. THE PATIENT CONTINUED TO FEEL WELL AND WAS NOT HOSPITALIZED. THE PATIENT RETURNED THE FOLLOWING DAY TO HAVE THE THORA VENT REMOVED AND REPORTED TOLERATED THE DEVICE WELL, NO SHORTNESS OF BREATH AS WELL AS NO SIGNIFICANT LEFT CHEST PAIN.

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 EXPERIENCED A PNEUMOTHORAX. THE LOCATION OF THE PNEUMOTHORAX WAS RIGHT LOWER LOBE. A CHEST TUBE WAS PLACED, AND PATIENT WAS HOSPITALIZED FOR OBSERVATION. THE CHEST TUBE WAS REMOVED 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: IT WAS REPORTED THAT AFTER A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE A PATIENT DEVELOPED AN IATROGENIC PNEUMOTHORAX IN THE LEFT UPPER LOBE (LUL). THE PATIENT HAD POSTPROCEDURAL CHEST X-RAYS AT 3:30 P.M. THAT DEMONSTRATED A SMALL APICAL 3-4 MM PNEUMOTHORAX. REPEAT CHEST X-RAY AT 6:30 P.M. SHOWED INCREASED PNEUMOTHORAX TO 1 CM DESPITE BEING ON A FULL-FACE MASK. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION AND PLACED ON 15 L SALTER CANNULA FOR SUPPORTIVE TREATMENT OF THE PNEUMOTHORAX. OVERNIGHT, THE PATIENT HAD REPEATED X-RAYS WHICH WAS FOUND TO BE STABLE AND THERE WAS NO EVIDENCE OF DESATURATION WITHOUT SUPPLEMENTAL O2. THE PATIENT WAS DISCHARGED 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: IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED BLEEDING. NO BLOOD TRANSFUSION AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PNEUMOTHORAX WAS DISCOVERED DURING ENDOBRONCHIAL ULTRASOUND. THE LOCATION OF THE PNEUMOTHORAX WAS RIGHT UPPER LOBE. A CHEST TUBE WAS PLACED, AND PATIENT WAS HOSPITALIZED FOR OBSERVATION. THE CHEST TUBE WAS REMOVED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2021.

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 BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET AND PNEUMOTHORAX WERE LOCATED RIGHT UPPER LOBE. AN ENDOBRONCHIAL ULTRASOUND WAS PERFORMED. A CHEST TUBE WAS PLACED IN THE PATIENT AND PATIENT WAS HOSPITALIZED. THE CHEST TUBE WAS REMOVED ON (B)(6) 2021. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2021.

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 BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE LOCATION WAS RIGHT UPPER LOBE. THE LOCATION OF THE PNEUMOTHORAX WAS RIGHT SIDE. DURING THE PROCEDURE THE PATIENT WENT INTO A COMPLETE HEART BLOCK AND BECAME HYPOTENSIVE. EPINEPHRINE WAS PUSHED INTO THE PATIENT¿S INTRAVENOUS TO TACKLE HYPOTENSION AND THE SCOPE WAS REMOVED IMMEDIATELY. THE CUSTOMER TOOK THE SCOPE OFF THE ROBOTIC ARMS AT THIS TIME AND WENT ON TO REMOVE THE SCOPE OUT OF PATIENT MANUALLY. THE PATIENT SUBSEQUENTLY BECAME STABLE, E.G., SHOWED INFERIOR WALL ACUTE MYOCARDIAL INFARCTION (AMI). THE PATIENT WENT TO THE CARDIAC CATHETERIZATION LAB IMMEDIATELY AND HAD AN EMERGENT ANGIOGRAM. THE PATIENT HAS RECOVERED AND HAS BEEN DISCHARGED.

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 EXPERIENCED A PNEUMOTHORAX. THE PNEUMOTHORAX WAS DISCOVERED VIA A CHEST X-RAY AFTER THE PROCEDURE WHEN THE PATIENT WAS AWAKE AND COMPLAINED ABOUT CHEST PAIN. THE TARGET AND PNEUMOTHORAX LOCATION WERE IN THE LEFT LOWER LOBE (LLL). A CHEST TUBE WAS PLACED IN THE PATIENT AND THE PATIENT WAS HOSPITALIZED. THE CHEST TUBE WAS REMOVED, AND PATIENT WAS DISCHARGED THE NEXT DAY.

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 BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE LOCATION WAS RIGHT UPPER LOBE. THE LOCATION OF THE PNEUMOTHORAX WAS RIGHT SIDE. DURING THE PROCEDURE THE PATIENT WENT IN CARDIAC ARREST FROM A TENSION PNEUMOTHORAX. A NEEDLE DECOMPRESSION WAS USED, AND PATIENT REGAINED THEIR PULSE. A CHEST TUBE WAS PLACED IN THE PATIENT AND THE PATIENT WAS HOSPITALIZED. THE CHEST TUBE WAS REMOVED ON (B)(6) 2021. THE PATIENT WAS DISCHARGED ON (B)(6) 2021.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING MEDICAL LITERATURE WAS REVIEWED: ROBOTIC BRONCHOSCOPY: AN INITIAL EXPERIENCE AT A TERTIARY CENTER. AUTHORS: GUSTAVO CUMBO-NACHELI, RONAK CHHAYA, AND JOHN EGAN. CITATION: CHEST ANNUAL MEETING 2019/ WEDNESDAY ELECTRONIC POSTERS 3/ VOLUME 156, ISSUE 4, SUPPLEMENT , A1767, OCTOBER 01, 2019/ DOI.ORG/10.1016/J.CHEST.2019.08.1538. TWO PATIENTS WERE REPORTED AS HAVING PNEUMOTHORAX AND REQUIRING CHEST TUBE PLACEMENT AS TREATMENT. 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: THE FOLLOWING MEDICAL LITERATURE WAS REVIEWED: ROBOT-ASSISTED BRONCHOSCOPY FOR PULMONARY LESION DIAGNOSIS: RESULTS FROM THE INITIAL MULTICENTER EXPERIENCE AUTHORS: UDIT CHADDHA, STEPHEN P. KOVACS, CHRISTOPHER MANLEY, D. KYLE HOGARTH, GUSTAVO CUMBO-NACHELI, SIVASUBRAMANIUM V. BHAVANI, ROHIT KUMAR, MANISHA SHENDE, JOHN P. EGAN III AND SEPTIMIU MURGU CITATION: BMC PULMONARY MEDICINE (2019) 19:243. DOI: HTTPS://DOI.ORG/10.1186/S12890-019-1010-8. FOUR PATIENTS WERE REPORTED AS HAVING PNEUMOTHORAX AND REQUIRING CHEST TUBE PLACEMENT AS TREATMENT. NO RELATED 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: ON 03/26/2021, IT WAS REPORTED THAT MAJOR BLEEDING WAS DISCOVERED IN A PATIENT SIX HOURS AFTER A MONARCH-ASSISTED BRONCHOSCOPIC PROCEDURE. THE LOCATION OF THE TARGET WAS THE RIGHT UPPER LOBE. THE POST PROCEDURE COMPUTED TOMOGRAPHY SCAN SHOWED A LARGE RIGHT SIDED PLEURAL EFFUSION AND A DROP IN HEMOGLOBIN THAT PROMPTED A RIGHT THORACOTOMY WITH EVACUATION OF THE HEMOTHORAX AND A RIGHT UPPER LOBE WEDGE RESECTION. NO OBVIOUS SITE OF THE BLEEDING WAS FOUND INTRAOPERATIVELY. THE PHYSICIAN BELIEVED THAT THE CAUSE OF THE BLEEDING WAS THE MASS ITSELF. THE PATIENT WAS NOT ON ANTICOAGULANTS AND THE BIOPSY POSSIBLY PRECIPITATED THE BLEEDING. THIS ADVERSE EFFECT IS RELATED TO THE PROCEDURE AND IS A RECOGNIZED OUTCOME OF A BRONCHOSCOPIC GUIDED LUNG BIOPSY. CONTRIBUTING FACTORS ARE THAT THE LESION WAS FOUND TO BE ADENOCARCINOMA AND MORE PRONE TO BLEEDING THAT NORMAL LUNG TISSUE. THE PATIENT DID REQUIRE A FOUR-UNIT BLOOD TRANSFUSION AND WAS DISCHARGED ON (B)(6) 2021.

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) 2021, IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE LOCATION OF THE TARGET AND PNEUMOTHORAX WERE IN THE ANTERIOR SEGMENT OF THE RIGHT UPPER LOBE. A CHEST TUBE WAS PLACED IN THE PATIENT AND THE PATIENT WAS HOSPITALIZED. AFTER BEING ADMITTED, THE PATIENT SUBSEQUENTLY BECAME SEPTIC, WAS DIAGNOSED WITH TUBERCULOSIS, AND REQUIRED CARE IN THE MEDICAL INTENSIVE CARE UNIT. THE PATIENT IS REPORTED AS DOING WELL BUT HAS NOT BEEN DISCHARGED DUE TO THEIR (B)(6) DIAGNOSIS.

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) 2021, IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, A PNEUMOTHORAX WAS IDENTIFIED. THE LOCATION OF THE TARGET WAS IN THE LOWER LEFT LOBE. THE LOCATION OF THE PNEUMOTHORAX WAS IN UPPER LEFT LOBE. THE CUSTOMER DID REPORT THAT THE PATIENT WAS IN SOME PAIN. A CHEST TUBE WAS PLACED IN THE PATIENT, AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT IS DOING WELL.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 2/19/2021, IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE ON (B)(6) 2021, A PNEUMOTHORAX WAS IDENTIFIED. THE PATIENT HAD A SMALL PNEUMOTHORAX IN THE RIGHT UPPER LOBE THAT DID NOT REQUIRE INTERVENTION. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON THE SAME DAY. DURING A POST-PROCEDURE FOLLOW-UP ON (B)(6) 2021, IT WAS OBSERVED THAT THE PNEUMOTHORAX HAD GROWN ABOUT 40 TO 50% FROM THE ORIGINAL SIZE. A CHEST TUBE WAS PLACED AND THE PATIENT WAS RELEASED THE SAME DAY. IT WAS REPORTED THAT THE PATIENT IS DOING FINE AND DID NOT REQUIRE ANY ADDITIONAL CARE.

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) 2021, ITS WAS REPORTED THAT AFTER A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, A PNEUMOTHORAX WAS IDENTIFIED DURING POST-PROCEDURE SCREENING. INITIALLY, THE PATIENT HAD A 5 TO 10% PNEUMOTHORAX IN THE LEFT UPPER LOBE. DURING THE CASE, MONARCH FORCEPS AND MEDTRONIC ARCPOINT NEEDLE WERE USED. THE PATIENT WAS RELEASED FROM THE HOSPITAL THE SAME DAY BUT WAS ASKED TO RETURN THE FOLLOWING DAY FOR AN X-RAY. DURING THE X-RAY, IT WAS OBSERVED THAT THE PNEUMOTHORAX WAS GROWN 40 TO 50% FROM THE ORIGINAL SIZE. A CHEST TUBE WAS PLACED AND THE PATIENT WAS RELEASED THE SAME DAY. IT WAS REPORTED THAT THE PATIENT IS DOING FINE AND DID NOT REQUIRE ANY ADDITIONAL CARE OR INTERVENTION.

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) 2021, IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT WAS OBSERVED TO HAVE A PNEUMOTHORAX. THE TARGET LOCATION WAS RIGHT UPPER LOBE. THERE WAS NO ALLEGATION OF DEVICE FAILURE. A CHEST TUBE WAS PLACED AND THE PATIENT WAS HOSPITALIZED. CHEST TUBE WAS REMOVED ON (B)(6) 2021. THE PNEUMOTHORAX WAS RESOLVED, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2021.

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.

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.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PHYSICIAN REPORTED A PNEUMOTHORAX 2 HOURS POST PROCEDURE AND REQUIRED CHEST TUBE PLACEMENT. THE PATIENT WAS ADMITTED FOR OBSERVATION AND RELEASED UPON THE PNEUMOTHORAX RESOLVING ITSELF WITH NO RESIDUAL EFFECTS.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A POST PROCEDURE X-RAY INDICATED A 10% PNEUMOTHORAX. A CHEST TUBE WAS USED AND THE PATIENT WAS ADMITTED FOR OBSERVATION OVERNIGHT. THE CHEST TUBE WAS REMOVED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITHOUT INCIDENT.