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 — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING ARTICLE HAS BEEN REVIEWED: MCNIERNEY D, CHEN J, ZEIN JG, VASZAR L, SWANSON K, AZADEH N, SAKATA KK. COMPARING MONARCH VERSUS ION ROBOTIC-ASSISTED BRONCHOSCOPY PLATFORMS: A PROPENSITY SCORE-MATCHED ANALYSIS. J BRONCHOLOGY INTERV PULMONOL. 2025 JUL 15;32(4):E01019. DOI: 10.1097/LBR.0000000000001019. PMID: 40662912, AND CITED FOUR (4) INSTANCES OF PNEUMOTHORAX WITH CHEST TUBE PLACEMENT. THIS REPORT IS BEING SUBMITTED FOR THESE EVENTS.

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 BRONCHOSCOPY PROCEDURE, THE PHYSICIAN ENCOUNTERED CART BOOT UP ISSUE AND ELECTED TO ABORT THE CASE. 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: IT WAS REPORTED THAT THE PHYSICIAN STARTED THE CASE WITH ENDOBRONCHIAL ULTRASOUND (EBUS) AND THEN SWITCHED TO MONARCH. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED SYSTEM FAULT MESSAGES AND ELECTED TO ABORT THE CASE. 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: IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE, THE PHYSICIAN ENCOUNTERED NAVIGATION ISSUES AND ELECTED TO ABORT THE CASE. 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: IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED SYSTEM FAULT MESSAGES AND ELECTED TO ABORT THE CASE. 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: IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED NAVIGATION ACCURACY ISSUES AND ELECTED TO ABORT THE CASE. 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: DURING MULTIPLE PROCEDURES, THE MONARCH ROBOT NAVIGATION SYSTEM WAS UNSURE WHICH AREA OF THE LUNG IT WAS IN WITH DISTANCE MEASUREMENTS VARYING UP TO 30MM. BIOMED WAS ABLE TO RECREATE PRODUCT ISSUE IN DEMO ENVIRONMENT. PROBLEMS INTERMITTENTLY BEGAN AFTER SOFTWARE UPDATE 5 WEEKS AGO BUT BECAME MORE CONSISTENT LAST WEEK.

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 BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED SYSTEM FAULT MESSAGES AND ELECTED TO ABORT THE CASE. 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: IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED SYSTEM FAULT MESSAGES AND ELECTED TO ABORT THE CASE. 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: IT WAS REPORTED THAT AFTER A SUCCESSFUL ROBOTIC BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. A VALVE WAS PLACED AND PATIENT WAS HOSPITALIZED. 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 AFTER A SUCCESSFUL ROBOTIC BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. A CHEST TUBE WAS PLACED. NO SYSTEM 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 ROBOTIC BRONCHOSCOPY PROCEDURE THE PHYSICIAN HAD DIFFICULTY WITH THE PATIENT SENSORS AND ELECTED TO ABORT THE CASE. 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: IT WAS REPORTED THAT DURING THE MONARCH BRONCHOSCOPY PROCEDURE, THE PHYSICIAN WAS PERFORMING THE BRONCHOALVEOLAR LAVAGE (BAL) WHEN THE PATIENT HAD A CARDIAC ARREST. THE PHYSICIAN WAS ABLE TO CONFIRM A PULSE BACK ON THE PATIENT. THE PATIENT IS IN STABLE CONDITION.

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 PHYSICIAN USED EBUS TO TARGET THE RIGHT UPPER LOBE (RUL). THE PHYSICIAN NOTICED THROUGH HIS MANUAL SCOPE THAT THERE WAS A SMALL LACERATION ON THE MUCOSA OF THE POST INTERIOR WALL OF THE RIGHT MAIN STEM. THE PHYSICIAN WAS NOT SURE HOW THIS OCCURRED. THE PHYSICIAN DECIDED TO ABORT THE CASE BECAUSE THEY DID NOT WANT TO CAUSE ANY FURTHER INJURY. THE PATIENT DID NOT EXPERIENCE ANY BLEEDING UPON WAKING UP. NOTABLY, THE ANESTHESIOLOGIST SUGGESTED THAT THE PATIENT MAY HAVE HAD FRAIL TISSUE, AND THE PHYSICIAN RECALLED A SIMILAR INCIDENT FROM TWO YEARS PRIOR IN THE SAME LOCATION, WHICH HAD RESOLVED WITHOUT COMPLICATIONS.

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 BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED DIFFICULTY NAVIGATING AND ELECTED TO ABORT THE CASE. 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: IT WAS REPORTED THAT AFTER THE BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED MEDIASTINAL EMPHYSEMA, AS INDICATED BY THE POSTOPERATIVE CT EXAMINATION. AFTER A FOLLOW-UP CT SCAN DEMONSTRATED RECOVERY, THE PATIENT WAS DISCHARGED ON (B)(6), FOLLOWING A TOTAL HOSPITAL STAY OF 6 DAYS.

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 BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED SYSTEM FAULT MESSAGES AND ELECTED TO ABORT THE CASE. 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: IT WAS REPORTED THAT AFTER A ROBOTIC BRONCHOSCOPY PROCEDURE, THE PATIENT HAD A PNEUMOTHORAX. A CHEST TUBE WAS PLACED AND THE PATIENT WAS MONITORED. THE PNEUMOTHORAX RESOLVED AND THE PATIENT WAS DISCHARGED HOME SIX DAYS AFTER THE PROCEDURE.

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 (VIA MEDSUN UF/IMPORTER REPORT # (B)(4)) THAT AFTER THE MONARCH BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX.

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 PROCEDURE THE PHYSICIAN WAS UNABLE TO TURN THE BRONCHOSCOPE ON AFTER REMOVING THE SCOPE FROM THE PATIENT'S TRACHEA DUE TO THE CAMERA IMAGE BEING GRAINY AND ULTIMATELY GOING BLACK. THE PHYSICIAN ELECTED TO ABORT THE CASE. 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: IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED SYSTEM FAULT MESSAGES AND ELECTED TO ABORT THE CASE. 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: IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN WAS UNABLE TO QUERY PACS (PICTURE ARCHIVING AND COMMUNICATION SYSTEM) AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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 — 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 BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED SYSTEM FAULT MESSAGES AND ELECTED TO ABORT THE CASE. 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: IT WAS REPORTED AFTER THE MONARCH BRONCHOSCOPY CASE WAS COMPLETED SUCCESSFULLY PATIENT EXPERIENCED A PNEUMOTHORAX SAME DAY. CHEST TUBE IS BEING EMPLANED TO ADDRESS PNEUMOTHORAX. PHYSICIAN DOES NOT ATTRIBUTE THIS EVENT TO MONARCH AND CONSIDERS IT A NORMAL RISK OF A PLURAL TARGET.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A MONARCH BRONCHOSCOPY PROCEDURE, THERE WAS A SIGNIFICANT CHANGE IN THE PATIENT'S VITAL SIGNS, PROMPTING INTERVENTION BY THE ANESTHESIOLOGIST. THE PATIENT, WHO WAS ELDERLY, EXPERIENCED A CARDIAC EVENT, AND THE PROCEDURE WAS SUBSEQUENTLY ABORTED. THE ATTENDING PHYSICIAN CONFIRMED THAT THE PATIENT HAD SUFFERED A HEART ATTACK. THE PATIENT WAS TRANSFERRED TO THE CATH LAB AND, UNFORTUNATELY, PASSED AWAY LATER THAT DAY. IT IS NOTED THAT THE CLINICAL STAFF DOES NOT ATTRIBUTE THE PATIENT EVENT TO THE MONARCH ROBOT.

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 DURING THE MONARCH BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A BLEED. THE PHYSICIAN REPORTED THE BLEEDING WAS NOT DUE TO MONARCH BUT RATHER JUST A RISK OF BIOPSYING THIS SPECIFIC PATIENT. THE PATIENT WAS ADMITTED FOR OBSERVATION ONLY.

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 THE MONARCH BRONCHOSCOPY PROCEDURE THE ARMS WERE STUCK IN STOW POSITION AND WILL NOT RESPOND. THE PHYSICIAN POWER CYCLED THE MONARCH SYSTEM A COUPLE OF TIMES AND RECONNECTED THE SYSTEM; HOWEVER, THERE WAS NO CHANGE. THE PHYSICIAN ELECTED TO ABORT THE CASE AND RESCHEDULE FOR A LATER DATE. THERE WAS NO REPORT OF AN ADVERSE EVENT DUE TO SYSTEM ISSUES.

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 THE PROCEDURE PATIENT EXPERIENCE ABDOMINAL DISTENTION AND RESPIRATORY DISTRESS AND WAS HOSPITALIZE AND DRAIN PLACEMENT WAS PERFORM.

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 BRONCHOSCOPY PROCEDURE THERE WAS PATIENT COMPLICATIONS. THE PATIENT HAD SEVERE HYPOXEMIA. THE PHYSICIAN HIT A VESSEL. AFTER REMOVING THE SCOPE THE PATIENT STARTED TO HEMORRHAGE. THE PHYSICIAN STABILIZED THE HEMORRHAGE WITH A MANUAL SCOPE AND COMPLETED THE PROCEDURE SUCCESSFULLY. THE CHEST TUBE WAS PLACED AND PATIENT WAS HOSPITALIZED AND RELEASED.

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 ALL THE USERS PASSWORDS HAD EXPIRED AND THEY WERE UNABLE TO LOGIN TO THE MONARCH SYSTEM. THE PHYSICIAN ELECTED TO ABORT THE CASE AND RESCHEDULED.

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 WHILE DRIVING IN THE RIGHT UPPER LOB (RUL), AND 25MM OUT FROM THE TARGET, USER DECIDED TO DO A SPIN TO CONFIRM HE WAS IN LINE WITH THE LESION AND GET READY TO PLACE A DYED COIL. THE SPIN WAS DONE AND THE SCOPE WAS OBSERVED TO BE THROUGH THE LUNG AND INTO THE PLEURAE WHILE THE SYSTEM WAS SHOWING THEY WERE 25MM OUT, RESULTING IN A PNEUMOTHORAX.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE CLINICAL SPECIALIST REPORTED THAT DURING THE PROCEDURE, THE LIVE CAMERA VIEW ON THE SCOPE SUDDENLY BECAME STATIC AND FUZZY, LEADING TO A LOSS OF VIEW. THE USER SWITCHED SCOPES AND SUCCESSFULLY NAVIGATED TO THE LESION. HOWEVER, WHILE BIOPSYING, AN FAULT OCCURRED, INDICATING DISCONNECTION OF THE SCOPE AND DISABLING OF ROBOTIC FUNCTIONS. DESPITE ATTEMPTS, THE USER COULDN'T TURN THE CAMERA BACK ON OR CLEAR THE ERROR. THE CLINICAL SPECIALIST MENTIONED THAT THE ISSUE RECURRED WITH THE SECOND SCOPE DURING BIOPSYING. CONSEQUENTLY, THE PHYSICIAN DECIDED TO END THE PROCEDURE WITHOUT FURTHER BIOPSIES. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SCOPE ISSUES.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE CLINICAL SPECIALIST REPORTED THAT DURING THE PROCEDURE, THE LIVE CAMERA VIEW ON THE SCOPE SUDDENLY BECAME STATIC AND FUZZY, LEADING TO A LOSS OF VIEW. THE USER SWITCHED SCOPES AND SUCCESSFULLY NAVIGATED TO THE LESION. HOWEVER, WHILE BIOPSYING, AN FAULT OCCURRED, INDICATING DISCONNECTION OF THE SCOPE AND DISABLING OF ROBOTIC FUNCTIONS. DESPITE ATTEMPTS, THE USER COULDN'T TURN THE CAMERA BACK ON OR CLEAR THE ERROR. THE CLINICAL SPECIALIST MENTIONED THAT THE ISSUE RECURRED WITH THE SECOND SCOPE DURING BIOPSYING. CONSEQUENTLY, THE PHYSICIAN DECIDED TO END THE PROCEDURE WITHOUT FURTHER BIOPSIES. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SCOPE ISSUES.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A DIAGNOSTIC MONARCH BRONCHOSCOPY, THE PHYSICIAN BIOPSIED SAMPLES AT THE RIGHT UPPER LOBE (RUL) 3CM FROM THE TARGET. AS THE PHYSICIAN REPOSITIONED THE BRONCHOSCOPE, A ROBOTIC ARM FAULT STATE OCCURRED. THE PHYSICIAN WAS NOT ABLE TO GET ALL OF HIS BIOPSIES DUE TO THIS FAULT CONDITION AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SYSTEM ISSUES.

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 EXPERIENCED A PNEUMOTHORAX MEDIASTINAL. NO MEDICAL INTERVENTION WAS REQUIRED. HOWEVER, THE PATIENT WAS HOSPITALIZED DUE TO OTHER MEDICAL ISSUES, FOR OBSERVATION ONLY UNRELATED TO MONARCH DEVICE. THERE WERE NO FAULTS OR ISSUES REPORTED WITH THE MONARCH SYSTEM AND THE PHYSICIAN IS NOT ATTRIBUTING THE EVENT TO THE MONARCH.

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 DIAGNOSTIC MONARCH BRONCHOSCOPY PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY WHILE DRIVING THROUGH THE BRONCHIAL ANATOMY TO THE TARGET LOCATION IN THE RIGHT UPPER LOBE (RUL). THE PATIENT ANATOMY REQUIRED THE BRONCHOSCOPE TO MANEUVER THROUGH A DIFFICULT/TIGHT SHARP TURN. THE MONARCH SYSTEM PRODUCED MULTIPLE FAULT CODES. THE PHYSICIAN WAS NOT ABLE TO REACH THE TARGET AND ELECTED TO ABORT THE DIAGNOSTIC PROCEDURE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SYSTEM ISSUES.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: HELLO, THIS IS CONCERNING A DEFECTIVE MEDICAL DEVICE. THE DEVICE: THE MONARCH. MY PULMONOLOGIST USED IT AS HE HAD DONE WITH THE OTHER 300 PATIENTS BEFORE ME, TO PLACE A MARKER IN MY LUNG. I HAVE A POSSIBLE MALIGNANT NODULE. THE SURGEON WENT IN TO TAKE OUT THE NODULE BUT COULD NOT FIND IT. THE MARKER WAS IN THE WRONG PLACE!!! MY PULMONOLOGIST CALLED MONARCH BUT GOT NOWHERE. HE DID FIND OUT THEY HAD RECENTLY DID A SOFTWARE UPDATE. SOMETHING WAS DEFECTIVE IN THE MONARCH DEVICE USED. MY DOCTOR PUT IN A COMPLAINT WITH THE FDA. ANOTHER PROVIDER AT THE LUNG CLINIC, ALSO HAD A MALFUNCTION WITH THE MONARCH ON A RECENT PATIENT. HE ALSO REPORTED TO THE FDA. MY PULMONOLOGIST AND IS GROUP WILL BE TALKING WITH THE HOSPITAL ABOUT THIS DEVICE AND IF THEY SHOULD CONTINUE TO USE IT OR CHANGE TO SOMETHING ELSE. THE MONARCH MALFUNCTION HAS DERAILED EVERYTHING WITH MY CARE REGARDING GETTING THIS NODULE REMOVED. I HAVE SO MUCH INFLAMMATION SINCE THE SURGERY THAT I MUST WAIT UNTIL JUNE FOR ANOTHER CT (COMPUTED TOMOGRAPHY) TO CHECK ON THE NODULE. OVER (B)(6) IN DOCTOR BILLS AND A SURGERY THAT I SHOULD NOT HAVE HAD BECAUSE OF THE DEFECT. **PROCEDURE OCCURRED AT (B)(6) OPERATING ROOM. THANK YOU, (B)(6). I H

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING THE CLINICAL STUDY TRIAL CASE UNEXPECTED VIDEO QUALITY WAS OBSERVED ON URETEROSCOPE. THE UNEXPECTED VIDEO QUALITY CONSISTED OF BLURRINESS ON THE SYSTEM DISPLAY. THE BLURRY VISION WAS ONLY OBSERVED DURING MINI-PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE OF THE PRODUCT WORKFLOW, NAMELY DURING URETEROSCOPE DRIVING WITH THE LASER DRIVER COMPONENT CONNECTED. UPON REPLACEMENT OF THE URETEROSCOPE, NO FURTHER VIDEO ISSUES WERE OBSERVED AND THE USER COMPLETED THE CASE. UNDER PRELIMINARY INVESTIGATION THE URETEROSCOPE WAS EXAMINED UNDER MAGNIFICATION, AT WHICH TIME IT WAS DISCOVERED THAT THE TOP LAYER OF THE CAMERA LENS WAS MISSING. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SYSTEM ISSUES.

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 BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX IN THE RIGHT LUNG. A CHEST TUBE WAS PLACED AND PATIENT WAS HOSPITALIZED. THE FOLLOWING DAY THE CHEST TUBE WAS REMOVED AND THE PATIENT WAS RELEASED. THE PHYSICIAN STATED THAT THE SCOPE APPEARED TO BE KINKED AND THE PHYSICIAN ELECTED TO ABORT THE CASE.

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 REPORTED THAT THE NAVIGATION WAS NOT MATCHING UP WITH THE CIOS SPIN AND WAS ~30MM OFF FROM THE TARGET BUT THE CASE WAS COMPLETED SUCCESSFULLY. A PNEUMOTHORAX WAS DISCOVERED POST-OP AND THE PATIENT WAS NOT ADMITTED BUT A CHEST TUBE WAS PLACED. CHEST TUBE WAS REMOVED SAME DAY AND THE PATIENT WENT HOME SAME DAY. THERE WERE NO FAULTS OR ISSUES REPORTED WITH THE MONARCH SYSTEM AND THE PHYSICIAN IS NOT ATTRIBUTING THE EVENT TO THE MONARCH.

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 DURING A MONARCH BRONCHOSCOPY PROCEDURE AN E-STOP ERROR OCCURRED. THE PHYSICIAN WAS UNABLE TO CLEAR THE E-STOP ERROR AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SYSTEM ISSUES.

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 SUCCESSFUL DIAGNOSTIC PROCEDURE USING THE MONARCH BRONCHOSCOPY SYSTEM, THE PATIENT DEVELOPED A PNEUMOTHORAX AND LATER PASSED AWAY. THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE ADVERSE EVENT. PER THE ACCOUNT MANAGER, HOSPITAL ENDO MANAGEMENT DOES NOT ATTRIBUTE THE PNEUMOTHORAX OR THE SUBSEQUENT DEATH TO ANY DEFICIENCY OF THE MONARCH SYSTEM.

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 BRONCHOSCOPY PROCEDURE THE PHYSICIAN WAS ADJUSTING THE SCOPE TOWARDS TARGET OF NODULE AND THE PATIENTS HEART RATE (HR) BEGAN TO DECLINE AND THE PHYSICIAN ABORTED THE CASE. THE PATIENT THEN WENT INTO ASYSTOLE AND REQUIRED EMERGENT CONVERSION AND CHEST COMPRESSIONS. ONCE THE PATIENT REGAINED A PULSE THE WERE TRANSPORTED THE INTENSIVE CARE UNIT (ICU) WHERE THE PATIENT CODED AGAIN AND WAS BEING SENT TO THE CARDIAC CATH LAB. THE PHYSICIAN STATED THAT THE ADVERSE EVENTS ARE NOT ATTRIBUTED TO THE MONARCH SYSTEM.

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 BRONCHOSCOPY PROCEDURE THE PHYSICIAN WAS ADJUSTING THE SCOPE TOWARDS TARGET OF NODULE AND THE PATIENTS HEART RATE (HR) BEGAN TO DECLINE AND THE PHYSICIAN ABORTED THE CASE. THE PATIENT THEN WENT INTO ASYSTOLE AND REQUIRED EMERGENT CONVERSION AND CHEST COMPRESSIONS. ONCE THE PATIENT REGAINED A PULSE THE WERE TRANSPORTED THE INTENSIVE CARE UNIT (ICU) WHERE THE PATIENT CODED AGAIN AND WAS BEING SENT TO THE CARDIAC CATH LAB. THE PHYSICIAN STATED THAT THE ADVERSE EVENTS ARE NOT ATTRIBUTED TO THE MONARCH SYSTEM.

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 REPEATED SYSTEM FAULTS OCCURRED DURING A MONARCH BRONCHOSCOPY. THE PHYSICIAN TRIED MULTIPLE BRONCHOSCOPES, BUT THE SYSTEM CONTINUED TO FAULT. THE PHYSICIAN ELECTED TO ABORT THE DIAGNOSTIC PROCEDURE. NO CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED DUE TO THIS EVENT.

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 PHYSICIAN OBSERVED EXCESS AMOUNT OF BLOOD IN THE AIR WAY AFTER SUCCESSFULLY COMPLETING THE MONARCH BRONCHOSCOPY PROCEDURE. THE PHYSICIAN ELECTED TO USE THEIR MANUAL BRONCHOSCOPE AND COLD SALINE TO CLEAR THE AIRWAY; HOWEVER, COMPLICATIONS OCCURRED DURING THE POST-MONARCH BRONCHOSCOPY PROCEDURE. THE PATIENTS BLOOD HAD CLOTTED AND BLOCKED THE ENDOTRACHEAL TUBE (ET TUBE). THE PATIENT THEN FELL INTO CARDIAC ARREST DUE TO LACK OF VENTILATION FROM THE FROM THE BLOOD CLOT BEING PRESENT IN THE ENDOTRACHEAL TUBE (ET TUBE). THE PHYSICIAN FOLLOWED CARDIAC ARREST PROTOCOL AND WAS ABLE TO RECOVER THE PATIENT. THE PATIENT WAS ADMITTED INTO INTENSIVE CARE UNIT (ICU) ON THE SAME DAY. AFTER THE PATIENT WAS SENT TO RECOVERY IN THE INTENSIVE CARE UNIT (ICU), THE PATIENT WAS GIVEN A CHEST X-RAY WHERE DOCTOR DISCOVERED THE PATIENT HAD EXPERIENCED A PNEUMOTHORAX. A CHEST TUBE WAS PLACED AND REMOVED THE FOLLOWING DAY. THE PHYSICIAN STATED THE PNEUMOTHORAX WAS DUE TO LONG BAG VENTILATION TIME, EXCESS SUCTION, AND OVER ALL STRESS ON THE LUNG THAT OCCURRED DURING BLEEDING MANAGEMENT POST-MONARCH PROCEDURE. THE PATIENT HAS BEEN RELEASED FROM THE HOSPITAL.

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 DIAGNOSTIC PROCEDURE USING THE MONARCH BRONCHOSCOPY SYSTEM, THE PHYSICIAN DECIDED TO ABORT THE DIAGNOSTIC PROCEDURE DUE TO NAVIGATIONAL DIFFICULTY AND POOR VISIBILITY. PATIENT MUCUS CONTRIBUTED SIGNIFICANTLY TO THE POOR VISIBILITY. THE PHYSICIAN DECIDED TO CONVERT THE DIAGNOSTIC PROCEDURE TO A MANUAL BRONCHOSCOPY PROCEDURE. IT WAS REPORTED THAT THE PATIENT DEVELOPED A PNEUMOTHORAX AND A CHEST TUBE WAS PLACED.

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 SYSTEM FAULT OCCURRED DURING SETUP FOR A MONARCH BRONCHOSCOPY. THE PHYSICIAN ELECTED TO NOT START THE DIAGNOSTIC PROCEDURE. THE PATIENT HAD ALREADY BEEN ANESTHETIZED. NO CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED DUE TO THIS EVENT. (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, AURIS HEALTH, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.