Monarch Endoscopy Platform (P1) System, Refurbished MON-000005-01RRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI B634MON00000501R0), received between Jun 29, 2022 and Feb 5, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Application Program Problem” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2026Application Program Problem

  IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED A SYSTEM ISSUES 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 24274532 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Pneumothorax

  MAUDE report 22804836 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Cardiac Arrest

  MAUDE report 21862284 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Pneumothorax

  MAUDE report 21715712 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19274504 ↗
• 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 804-47-1-1 (PDU E-STOP ERROR). THE PROGRAM DEVELOPMENT MANAGER POWER CYCLED THE SYSTEM AND REPORTED THAT THE CART WAS NOT PRODUCING THE INITIALIZATION CLICKS BEFORE THE FAULT PRODUCED. THE CUSTOMER POWERED DOWN THE SYSTEM AND REVIEWED THE PINS INSIDE THE UMBILICAL CABLE CONNECTOR AS DISCOVERED ONE PIN WAS RECESSED IN THE UMBILICAL CABLE CONNECTOR. A PHYSICAL EXAMINATION OF THE CABLE ASSEMBLY SHOWED NO DAMAGES. A VISUAL EXAMINATION OF THE CABLE CONNECTOR DID CONFIRM MULTIPLE PINS WERE RECESSED. THE PROCEDURE WAS CANCELED THAT DAY AND COMPLETED 2-DAYS LATER SUCCESSFULLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14948417 ↗
• InjuryJun 29, 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, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET LOCATION WAS NEXT TO A FISSURE. A CHEST TUBE WAS PLACED. THE PROCEDURE HAS NOT BEEN RESCHEDULED TO DATE.

  Patient problems: Pneumothorax

  MAUDE report 14856504 ↗

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