BRONCHOVIDEOSCOPE OLYMPUS BF-H1100Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 04953170424229), received between May 26, 2023 and Oct 20, 2025 — classified as 59 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (28 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K250862); 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.

Recalls naming this device

1. Sep 11, 2025Class IOpen, Classified

   Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

   Z-0052-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED THE DISTAL END HAD A BURN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336028 ↗
• MalfunctionSep 2, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS OBSERVED DURING OLYMPUS' DEVICE INSPECTION THAT THE BRONCHOVIDEOSCOPE DISPLAYED A B30 SCOPE COMMUNICATION ERROR. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22943184 ↗
• MalfunctionFeb 24, 2025No Display/Image; Communication or Transmission Problem; No Display/Image; Communication or Transmission Problem

  IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE BRINCHOVIDEO SCOPE EXHIBITED NO IMAGE AND ERROR MESSAGE E226 (SCOPE COMMUNICATION ERROR). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21450430 ↗
• MalfunctionJan 16, 2025Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THE SUBJECT DEVICE IMAGE WAS FLICKERING WHEN WAS CONNECTED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21167476 ↗
• MalfunctionJan 3, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THE BRONCHOVIDEOSCOPE EXPERIENCED A B30 SCOPE COMMUNICATION ERROR AND AN E226 SCOPE COMMUNICATION ERROR. THE ISSUE OCCURRED DURING SETUP/INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21069118 ↗
• MalfunctionNov 27, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THE SUBJECT DEVICE HAD NO CONNECTION TO THE PROCESSOR AND IMAGE FAULT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20800855 ↗
• MalfunctionNov 18, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHO VIDEOSCOPE EXHIBITED A BURN ON THE PLASTIC DISTAL END COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20706651 ↗
• MalfunctionNov 6, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS OBSERVED, THAT DURING DEVICE EVALUATION. THE BRONCHOVIDEOSCOPE PLASTIC DISTAL END COVER MELTED OR BURNED AROUND THE INSTRUMENT CHANNEL OUTLET AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20616446 ↗
• MalfunctionOct 28, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THE BRONCHOVIDEOSCOPE HAD NO IMAGE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20545121 ↗
• MalfunctionOct 18, 2024No Display/Image; No Display/Image

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOVIDEOSCOPE EXHIBITED NO IMAGE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20482396 ↗
• MalfunctionOct 17, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THE BRONCHOVIDEOSCOPE EXHIBITED ERROR CODE E315, FAILURE TO CONNECT THE EQUIPMENT TO THE UNIT. THE ISSUE OCCURRED BEFORE THE UNSPECIFIED PROCEDURE BEGAN (DURING PREPARATION FOR USE). THE INTENDED PROCEDURE COULD NOT BE COMPLETED AND WAS CANCELLED. IT WAS REPORTED THAT THE PATIENT WAS NOT SEDATED AT THE TIME. NO PATIENT ADVERSE EFFECTS REPORTED. THERE HAVE BEEN NO REPORTS OF ANY PATIENT INJURY OR SERIOUS DETERIORATION IN THEIR HEALTH FROM THE CANCELLED PROCEDURE NOR WAS THERE ANY INDICATION THAT THE PROCEDURE WAS BEING DONE EMERGENTLY/URGENTLY FOR LIFE-THREATENING REASONS. THERE WAS NO EVIDENCE THAT THE PATIENT DEVELOPED A PERMANENT DISABILITY OR PERMANENT DAMAGE THAT CAUSED SUBSTANTIAL DISRUPTION IN THEIR ABILITY TO CONDUCT NORMAL LIFE FUNCTIONS, AND THAT ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR DAMAGE TO A BODY STRUCTURE THAT IS ASSOCIATED WITH THE USE OF THE OLYMPUS DEVICE. THIS EVENT WILL BE REASSESSED FOR POTENTIAL CHANGE IN REPORTABILITY IF FURTHER INFORMATION IS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20473046 ↗
• MalfunctionOct 14, 2024No Display/Image; No Display/Image

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE CAMERA CONTROL UNIT EXHIBITED NO IMAGE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20441392 ↗
• MalfunctionOct 1, 2024Break; Break

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE BRONCHOVIDEOSCOPE EXHIBITED IMAGE ISSUE WITH PROBABLE CAUSE OF ISSUE BEING THE RESULT OF SHOCK, WHICH DAMAGED THE UNIT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20346424 ↗
• MalfunctionSep 19, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED, THE BRONCHOVIDEOSCOPE EXHIBITED ERROR CODE E216. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20258568 ↗
• MalfunctionSep 16, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE BRONCHOVIDEOSCOPE HAD NO IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20232697 ↗
• MalfunctionSep 9, 2024Melted; Output Problem; Melted; Output Problem

  IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE DISTAL END OF THE BRONCHO-VIDEOSCOPE WAS MELTED AND THERE IS AN ERROR CODE (E217) DISPLAYED WHILE ADJUSTING THE WHITE BALANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20169919 ↗
• MalfunctionAug 13, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING A PREPARATION FOR USE, THE BRONCHOVIDEOSCOPE HAD NO SIGNAL, IMAGE, OR SOUND WHEN PLUGGED INTO THE VIDEO TOWER. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973624 ↗
• MalfunctionJul 18, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THE BRONCHOVIDEOSCOPE HAD SCOPE COMMUNICATION ERROR (E216). THE ISSUE OCCURRED DURING THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19773730 ↗
• MalfunctionJul 16, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED, THE BRONCHOVIDEOSCOPE EXHIBITED ERROR CODE B30. ADDITIONALLY, DURING DEVICE EVALUATION ERROR CODE E226 WAS DISPLAYED. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19751489 ↗
• MalfunctionJul 16, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THE BRONCHOVIDEOSCOPE EXHIBITED AN ERROR CODE E315 (NON-COMPATIBLE ENDOSCOPE). THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19751202 ↗
• MalfunctionJul 8, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE BRONCHOVIDEOSCOPE HAD NO IMAGE. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19689719 ↗
• MalfunctionJun 10, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE BRONCHOVIDEOSCOPE EXHIBITED A B30 ERROR (SCOPE COMMUNICATION ERROR). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19499968 ↗
• MalfunctionJun 7, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE BRONCHOVIDEOSCOPE EXHIBITED A SCOPE COMMUNICATION ERROR CODE B30. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484524 ↗
• MalfunctionJun 6, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THE BRONCHOVIDEOSCOPE HAD AN E315 INCOMPATIBLE SCOPE ERROR CODE. THE ISSUE OCCURRED DURING AN UNKNOWN EVENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19476455 ↗
• MalfunctionJun 3, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOVIDEOSCOPE EXHIBITED AN INCOMPATIBLE SCOPE ERROR (E315). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19447024 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K250862. One submission often covers many models, so check the product and lot details in each record.

• Z-0066-2026 · Sep 11, 2025 · Open, Classified
  EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
• Z-0048-2026 · Sep 11, 2025 · Open, Classified
  BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100
• Z-0057-2026 · Sep 11, 2025 · Open, Classified
  EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190