BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of BRONCHOVIDEOSCOPE (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus BF-1TH1100 bronchoscope is a flexible scope used to look inside the lungs and airways. The 54 reports mostly describe the scope's tip cover burning or melting when used with laser, argon plasma coagulation or high-frequency therapy equipment, along with loss of the video image and connection errors between the scope and its processor. No deaths and no injuries are described. One open recall, started in September 2025, adds instructions clarifying correct use of bronchoscopes alongside laser, argon plasma coagulation and high-frequency therapy equipment.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 54
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 04953170424199), received between Jul 10, 2023 and Dec 6, 2024 — classified as 54 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (18 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.
Reports received per month
Recalls naming this device
- 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-0048-2026 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- No Display/Image18
- Communication or Transmission Problem14
- Thermal Decomposition of Device6
- Microbial Contamination of Device4
- Detachment of Device or Device Component2
- Melted2
- Output Problem2
- Peeled/Delaminated2
Patient problems
- No Clinical Signs, Symptoms or Conditions54
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 6, 2024Break; Device Damaged by Another Device; Break; Device Damaged by Another Device
IT WAS REPORTED THE DISTAL END OF THE SUBJECT DEVICE BURNT AFTER USING ARGON PROBE. "ARGON PROBE IS SAID TO HAVE HAD A LATERAL CRACK". PER THE REPORT, THE ISSUE WAS FOUND "AFTER PROCEDURE (UPON COMPLETION OF PROCEDURE, DEVICE NO LONGER USED ON PATIENT). THERE WAS NO PATIENT HARM, NO INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20870104 ↗MalfunctionNov 12, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOVIDEOSCOPE¿S PLASTIC DISTAL END COVER WAS BURNED OR MELTED AROUND THE INSTRUMENT CHANNEL OUTLET AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20667253 ↗MalfunctionNov 7, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOVIDEOSCOPE¿S PLASTIC DISTAL END COVER WAS BURNED OR MELTED AROUND THE INSTRUMENT CHANNEL OUTLET AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20628798 ↗MalfunctionNov 6, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOVIDEOSCOPE¿S PLASTIC DISTAL END COVER WAS BURNED OR MELTED AROUND THE INSTRUMENT CHANNEL OUTLET AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20621582 ↗MalfunctionNov 4, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE'S PLASTIC DISTAL END COVER WAS BURNED/MELTED 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 20601828 ↗MalfunctionNov 4, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE'S PLASTIC DISTAL END COVER HAD BURNED OR MELTED AROUND THE INSTRUMENT CHANNEL OUTLET AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20600777 ↗MalfunctionOct 31, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT THERE WAS NO IMAGE ON THE BRONCHOVIDEOSCOPE. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20577425 ↗MalfunctionOct 30, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT THE BRONCHOVIDEOSCOPE DISPLAYED ERROR E216 (SCOPE COMMUNICATION ERROR). THE ISSUE OCCURRED DURING AN UNKNOWN EVENT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20569492 ↗MalfunctionOct 23, 2024No Display/Image; No Display/Image
IT WAS REPORTED, THE BRONCHOVIDEOSCOPE DID NOT TRANSFER THE IMAGE TO THE MONITOR. AND THERE WAS RANDOM IMAGE LOSS. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20513711 ↗MalfunctionOct 15, 2024No Display/Image; No Display/Image
IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE BRONCHOVIDEOSCOPE HAD NO IMAGE DURING ANGULATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20450959 ↗MalfunctionOct 9, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT THE BRONCHOVIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20411316 ↗MalfunctionOct 9, 2024Melted; Melted
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE BRONCHOVIDEOSCOPE EXHIBITED THE PROBE COVER WITH A BURN. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20410248 ↗MalfunctionOct 9, 2024No Display/Image; Output Problem; No Display/Image; Output Problem
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOVIDEOSCOPE EXHIBITED NO IMAGE AND AN E217 OUTPUT ERROR CODE WAS DISPLAYED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20408972 ↗MalfunctionOct 8, 2024No Display/Image; No Display/Image
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE IMAGE DISAPPEARED DURING THE UP ANGULATION ON THE BRONCHOVIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20404486 ↗MalfunctionOct 4, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT THE ENDOSCOPE CONSTANTLY REPORTS A COMMUNICATION ERROR (ERROR CODE B30). THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20371818 ↗MalfunctionOct 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE FRONT RING AT THE DISTAL END OF THE BRONCHOVIDEOSCOPE CAME LOOSE DURING AN UNSPECIFIED PROCEDURE. THE RING REMAINED ATTACHED TO THE DISTAL END UNTIL THE END OF THE PROCEDURE AND THEN FELL OFF DURING THE FIRST WIPE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20351663 ↗MalfunctionOct 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE BRONCHOVIDEOSCOPE'S BIOPSY CHANNEL BECAME LOOSE DURING AN UNSPECIFIED PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20350781 ↗MalfunctionSep 6, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THE BRONCHOVIDEOSCOPE HAD A COMMUNICATION ERROR WITH THE PROCESSOR. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20162691 ↗MalfunctionAug 22, 2024No Display/Image; No Display/Image
IT WAS REPORTED THE BRONCHOVIDEOSCOPE HAD NO IMAGE. THE ISSUE OCCURRED DURING PREPARATION FOR USE IN AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20024700 ↗MalfunctionAug 8, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT THE BRONCHOVIDEOSCOPE HAD NO IMAGE. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19940756 ↗MalfunctionJul 18, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THE BRONCHOVIDEOSCOPE HAD AN E216 SCOPE COMMUNICATION ERROR DURING A BRONCHOSCOPY PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE WITH A FEW MINUTES OF DELAY. THE PATIENT WAS IN SUPPRESSION BEFORE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19775041 ↗MalfunctionJul 11, 2024No Display/Image; No Display/Image
IT WAS REPORTED, THE BRONCHOVIDEOSCOPE IMAGE DOES NOT WORK WITH STRONG ANGULATION. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19719815 ↗MalfunctionJul 2, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED, THE BRONCHOVIDEOSCOPE HAD AN ERROR MESSAGE COME UP STATING CONTACT OLYMPUS "SCOPE COMMUNICATION ERROR" WHEN PLUGGING SCOPE INTO PROCESSOR. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19656656 ↗MalfunctionJun 28, 2024No Display/Image; No Display/Image
IT WAS REPORTED THE BRONCHOVIDEOSCOPE HAD SPORADIC IMAGE FAILURES. THE ISSUE OCCURRED DURING THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19632739 ↗MalfunctionJun 21, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THE BRONCHOVIDEOSCOPE HAD THE OCCASIONAL LOSS OF THE IMAGE. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR A BRONCHOSCOPY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19583314 ↗
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, ClassifiedEVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
- Z-0057-2026 · Sep 11, 2025 · Open, ClassifiedEVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190
- Z-0052-2026 · Sep 11, 2025 · Open, ClassifiedBRONCHOVIDEOSCOPE OLYMPUS BF-H1100
Other Bronchoscope (Flexible Or Rigid) devices
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)3 recalls5 deaths1,557 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls1 death1,214 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XP190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls1,146 reports
- Ion 380748Intuitive Surgical, Inc. · Bronchoscope (flexible or rigid)1 recall97 deaths1,278 reports
- VISERA ELITE XENON LIGHT SOURCE OLYMPUS CLV-S190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)1,155 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)5 recalls3 deaths621 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190Olympus Medical Systems Corp. · Bronchoscope (Flexible Or Rigid)3 recalls333 reports
- BRONCHOVIDEOSCOPE BF-1T150Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls212 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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