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 LOCATION WAS RIGHT UPPER LUBE (RUL), AND THE PNEUMOTHORAX WAS DISCOVERED WHEN THE PHYSICIAN USED FLUOROSCOPY AND NOTICED THAT THE PATIENT HAD A PNEUMOTHORAX FROM THE IMAGE. A CHEST TUBE WAS PLACED IN THE PATIENT, AND COUPLE HOURS LATER THE CHEST TUBE WAS REMOVED AND THE PATIENT WAS RELEASED FROM THE HOSPITAL 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: THE FOLLOWING MEDICAL LITERATURE WAS REVIEWED: ROBOTIC BRONCHOSCOPY: FACTORS ASSOCIATED WITH DIAGNOSTIC ACCURACY OF ROBOTIC BRONCHOSCOPY WITH 12-MONTH FOLLOW-UP: AUTHORS: ABHINAV AGRAWAL, MD, ELLIOT HO, DO, UDIT CHADDHA, MBBS, BARIS DEMIRKOL, MD, SIVASUBRAMANIUM V. BHAVANI, MD, D. KYLE HOGARTH, MD, FCCP, SEPTIMIU MURGU, MD, FCCP. CITATION:DOI:HTTPS://DOI.ORG/10.1016/J.ATHORACSUR.2021.12.041. IT WAS REPORTED PNEUMOTHORAX AND PATIENT HOSPITALIZE . 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 DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET LOCATION WAS RIGHT UPPER LUBE (RUL), AND THE PNEUMOTHORAX WAS DISCOVERED DURING POST-PROCEDURE CHEST X-RAY. A CHEST TUBE WAS PLACED IN THE PATIENT AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE CHEST TUBE WAS REMOVED FOUR DAYS AFTER THE 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: IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE A PATIENT EXPERIENCED BLEEDING DURING THE BRONCHOALVEOLAR LAVAGE (BAL). THE RIGHT UPPER LOBE (RUL) WAS VISUALIZED AND BLEEDING WAS IDENTIFIED AND ORIGINATED FROM THE POSTERIOR SEGMENT. A DROP IN SATURATIONS REQUIRED MANUAL BAGGING FOR VENTILATION. THE BLEEDING WAS SUCCESSFULLY TREATED WITH EPINEPHRINE AND BALLOON TAMPONADE. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO SUBSEQUENT COMPLICATION. THE PATIENT WAS EXTUBATED IN THE OPERATING ROOM (OR) AND WAS ADMITTED FOR FURTHER OBSERVATION AND WAS RELEASED 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 AFTER A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A SMALL PNEUMOTHORAX. THE PNEUMOTHORAX WAS DISCOVERED DURING POST-OP CHECK VIA A CHEST X-RAY. THE LOCATION OF THE PNEUMOTHORAX WAS LEFT UPPER LOBE (LUL). THE PNEUMOTHORAX WAS TREATED EXPECTANTLY WITH OXYGEN AND HOSPITALIZATION ON (B)(6) 2021. A SECOND CHEST X-RAY WAS TAKEN, AND 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: IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE LOCATION OF THE TARGET AND PNEUMOTHORAX WAS LEFT UPPER LOBE. IN ADDITION TO THE PNEUMOTHORAX, THE PATIENT SUFFERED AN ALLERGIC REACTION TO ANESTHETIC. A CHEST TUBE WAS PLACED TO TREAT THE PNEUMOTHORAX. THE CHEST TUBE WAS REMOVED, AND 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 THE PATIENT NOTIFIED THE PULMONOLOGY TEAM AT THE HOSPITAL TO PICK UP THE OXYGEN EQUIPMENT AS THE PATIENT DISCONTINUED OXYGEN THERAPY AND ASKED THAT THE EQUIPMENT BE PICKED UP.

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 RIGHT MIDDLE LOBE. A CHEST TUBE WAS PLACED, AND PATIENT WAS HOSPITALIZED FOR OBSERVATION. THE CHEST TUBE WAS REMOVED ON 8/11/21 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 THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE PNEUMOTHORAX WAS DISCOVERED DURING THE POST-OP CHEST X-RAY. THE LOCATION OF THE TARGET WAS RIGHT UPPER LOBE. A CHEST TUBE WAS PLACED, AND PATIENT WAS HOSPITALIZED. THE CHEST TUBE WAS REMOVED, AND THE PATIENT WAS DISCHARGED ON (B)(60 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 AFTER A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, PATIENT EXPERIENCED A PNEUMOTHORAX. THE BIOPSY OF A LESION IN THE RIGHT MIDDLE LOBE. THE LOCATION OF THE PNEUMOTHORAX WAS RIGHT SIDE. A CHEST TUBE WAS PLACED TO TREAT THE PNEUMOTHORAX. 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 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.