Monarch Endoscopy Platform (P1) Tower Upgrade MON-000005-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI B634MON000005010), received between Jun 15, 2022 and Sep 9, 2026 — classified as 1 death, 12 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K173760); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemothorax

  MAUDE report 50680849 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21359320 ↗
• DeathFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21337731 ↗
• MalfunctionNov 21, 2024Delayed Program or Algorithm Execution; Delayed Program or Algorithm Execution

  IT WAS REPORTED, THAT DURING THE MONARCH BRONCHOSCOPY PROCEDURE. CUSTOMER, EXPERIENCE INSTRUMENT STILL LOADED FAULT AND ROBOT JOINT ERROR. PHYSICIAN ELECTED TO ABORT THE PROCEDURE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT, BECAUSE OF THE SYSTEM ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20754177 ↗
• MalfunctionOct 25, 2024Intermittent Communication Failure; Intermittent Communication Failure

  IT WAS REPORTED THAT DURING THE MONARCH BRONCHOSCOPY PROCEDURE THEY WERE TRYING TO UN-STOW THE ARMS AND RECEIVED FAULTS. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20539444 ↗
• MalfunctionSep 13, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING THE MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN EXPERIENCED ISSUES WITH THE ROBOTIC ARM AND DECIDED TO ABORT THE CASE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SYSTEM ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20214179 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19706569 ↗
• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Pneumothorax

  MAUDE report 19251075 ↗
• InjurySep 7, 2023Application Program Problem; Insufficient Device Problem Information; Application Program Problem; Insufficient Device Problem Information

  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. THE PATIENT WAS REPORTED TO HAVE A LOT OF MUCUS. THE PHYSICIAN DECIDED TO ABORT THE DIAGNOSTIC PROCEDURE. THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE ADVERSE EVENT. NO MEDICAL OR SURGICAL INTERVENTION REPORTED. NO HOSPITALIZATION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17703360 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A SUCCESSFUL DIAGNOSTIC PROCEDURE USING THE MONARCH BRONCHOSCOPY SYSTEM, THE PATIENT REPORTED HAVING HYPOXIA WHICH IS A PRE-EXISTING CONDITION THAT IS ATTRIBUTED TO MEDICAL HISTORY OF COPD. THE PATIENT WAS HOSPITALIZED AND SUPPLEMENTAL OXYGEN (3L 02) WAS GIVEN AND RELEASED THE FOLLOWING DAY. NO ISSUES WERE REPORTED REGARDING THE MONARCH SYSTEM.

  Patient problems: Hypoxia

  MAUDE report 17687075 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A DIAGNOSTIC PROCEDURE USING THE MONARCH BRONCHOSCOPY SYSTEM, BLEEDING WAS NOTED. THE PHYSICIAN CONVERTED THE PROCEDURE TO A TRADITIONAL BRONCHOSCOPY AND A BALLOON WAS USED TO PROVIDE TAMPONADE. PER THE PHYSICIAN, THE PRIMARY CAUSE OF THE PATIENT BLEED WAS DUE TO THE PATIENT¿S FRAGILE AIRWAYS AND PRE-EXISTING CONDITION. THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE ADVERSE EVENT. NO HOSPITALIZATION REQUIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17618092 ↗
• InjuryAug 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A RECURRENT FAULT STATE OCCURRED DURING INITIAL SYSTEM REGISTRATION OF THE MONARCH BRONCHOSCOPY SYSTEM, PREVENTING THE USE OF THE SYSTEM. THE DIAGNOSTIC PROCEDURE WAS ABORTED. THE PATIENT HAD ALREADY BEEN ANESTHETIZED. NO CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17455864 ↗
• MalfunctionMar 14, 2023Electrical /Electronic Property Problem; Mechanics Altered; Electrical /Electronic Property Problem; Mechanics Altered

  DURING A MONARCH BRONCHOSCOPY PROCEDURE A 500-29-0-310 IDM TORQUE MISMATCH FAULT WAS REPORTED. THE PHYSICIAN WAS AT THE TARGET, AND WAS READJUSTING TO PLACE A FIDUCIAL, WHEN THE FAULT OCCURRED. THE ACCOUNT MANAGER POWERED DOWN THE SYSTEM AND ATTEMPTED TO RESTART, HOWEVER, THE FAULT PERSISTED WHEN THE ARMS WERE UN-STOWED. THE PHYSICIAN SWAPPED TO A SECOND SCOPE THE ISSUE CONTINUED. THE PHYSICIAN ELECTED TO ABORT THE CASE, WHICH IS TO BE RESCHEDULED. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SYSTEM ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538428 ↗
• MalfunctionFeb 23, 2023No Display/Image; Intermittent Communication Failure; No Display/Image; Intermittent Communication Failure

  IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE, THE PHYSICIAN ENCOUNTERED A SCOPE DISCONNECTED FAULT WHILE TAKING BIOPSIES. AS A RESULT OF THE SCOPE DISCONNECTED FAULT CONDITION, THE SYSTEM PROVIDES THE FOLLOWING MESSAGE TO THE USER: ¿WARNING: THE BRONCHOSCOPE CABLE HAS BEEN DISCONNECTED. LIVE BRONCHOSCOPE VIEW AND THE SYSTEM HAS BEEN HALTED TO PREVENT PATIENT INJURY. RECONNECT THE CABLE AND PRESS OK TO CONTINUE¿ THE HOSPITAL STAFF DISCONNECTED AND RECONNECTED THE CABLE, BUT THE LIVE VIDEO FEED WAS NOT REESTABLISHED. THE PHYSICIAN CHOSE TO ABORT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16431595 ↗
• MalfunctionSep 27, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THE PHYSICIAN LOST THE LIVE CAMERA IMAGE AFTER COMPLETING THE NAVIGATION REGISTRATION AND STARTED TO DRIVE OUT TO THE TARGET. THE PHYSICIAN PROACTIVELY POWER CYCLED THE SYSTEM AND CHANGED OUT THE SCOPE; HOWEVER THE ISSUE PERSISTED. THE PHYSICIAN WAS UNABLE TO PERFORM THE MONARCH PROCEDURE DUE TO THE SYSTEM RELATED ISSUE, THE CASE WAS ABORTED AND RESCHEDULED FOR A LATER DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15494493 ↗
• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A POST-PROCEDURE CXR (CHEST X-RAY) REVEALED A PNEUMOTHORAX, IN THE LEFT UPPER LOBE, IN A PATIENT HAD COME IN FOR A BRONCHOSCOPY PROCEDURE. THE PATIENT WAS HOSPITALIZED, AND A CHEST TUBE WAS PLACED. THE CHEST TUBE WAS REMOVED, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2022. THERE WERE NO FAULTS OR DEVICE MALFUNCTIONS REPORTED DURING THE PROCEDURE.

  Patient problems: Pneumothorax

  MAUDE report 15211833 ↗
• MalfunctionJul 7, 2022Unintended Application Program Shut Down; Unintended Application Program Shut Down

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MONARCH BRONCHOSCOPY PROCEDURE. DURING THAT PROCEDURE THE MONARCH SYSTEM REPORTED HAVING FAULT 804-46-0-0 (PDU E-STOP ERROR). THE BRONCHOSCOPE WAS REMOVED, AND THE MONARCH WAS POWER CYCLED. AFTER THE SYSTEM POWERED ON, THE SAME FAULT RETURNED. PROGRAM DEVELOPMENT MANAGER (PDM) CHECKED THE E-STOP BUTTON ON THE CART, AND IT WAS NOT ILLUMINATED, SO THE PDM WAS INSTRUCTED TO POWER CYCLE FROM THE TOWER SOFTWARE. ONCE THE SYSTEM WAS COMPLETELY OFF, PDM CHECKED THE UMBILICAL CABLE AND DISCOVERED A RECESSED PIN INSIDE THE UMBILICAL CABLE. THE PROCEDURE WAS ABORTED AND RESCHEDULED FOR A LATER DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14948071 ↗
• InjuryJul 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, IT WAS REPORTED THAT A PATIENT UNDERWENT A NAVIGATION BRONCHOSCOPY. DURING THE PROCEDURE, THE PATIENT WAS NOTED TO BE HYPOXIC, WITH ELEVATED PEAK PRESSURE. AN ULTRASOUND SHOWED NO LUNG SLIDING ON RIGHT, CHEST X-RAY (CXR) CONFIRMED A MODERATE-SIZED, RIGHT PNEUMOTHORAX WITH ASSOCIATED LEFTWARD DEVIATION OF THE MEDIASTINUM, RAISING THE POSSIBILITY OF TENSION PNEUMOTHORAX, AND LEFT BASILAR ATELECTASIS. A PIGTAIL CHEST TUBE WAS PLACED IN THE RIGHT UPPER CHEST. PATIENT TOLERATED THE PROCEDURE WELL. POST PROCEDURE CXR SHOWS RESOLUTION OF PNEUMOTHORAX. CHEST TUBE WAS REMOVED. THE PATIENT REMAINED IN THE HOSPITAL FOR 7-DAYS DUE TO SYMPTOMS OF ACUTE HYPOXIC RESPIRATORY FAILURE SECONDARY TO PNEUMOTHORAX. PEDIATRIC GI FORCEPS WERE USED DURING THE PROCEDURE AS WELL AS AN UNKNOWN NEEDLE.

  Patient problems: Pneumothorax

  MAUDE report 14919470 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE DUE TO CONCERNS FOR POTENTIAL PNEUMOTHORAX (HIGH PEAK PRESSURE AND DECLINING 02 SATURATIONS). THE PHYSICIAN OBTAINED A PORTABLE CHEST X-RAY (CXR) AND A LEFT SIDED PNEUMOTHORAX WAS NOTED. THE PHYSICIAN PROCEEDED TO PLACE A 14G WAYNE PNEUMOTHORAX CHEST TUBE AT THE BEDSIDE. THE PATIENT WAS ADMITTED FOR OBSERVATION. THE CHEST TUBE WAS REMOVED, AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

  Patient problems: Pneumothorax

  MAUDE report 14700731 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A NAVIGATIONAL BRONCHOSCOPY FOR SAMPLING OF THE RIGHT MIDDLE LOBE (RML). A RIGHT-SIDED PNEUMOTHORAX WAS NOTED, AND A PIGTAIL CHEST TUBE WAS PLACED. THE CATHETER WAS SUTURED IN PLACE AND ATTACHED TO-20CMH20 SUCTION. THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION. POST CHEST TUBE PLACEMENT CHEST X-RAYS (CXR) SHOWED RESOLUTION OF THE PNEUMOTHORAX. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

  Patient problems: Pneumothorax

  MAUDE report 14700524 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173760. One submission often covers many models, so check the product and lot details in each record.

• Z-0025-2020 · Apr 19, 2019 · Terminated
  Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120