PENTAX FB-15RBSRecalls & reported problems
Hoya Corporation · PORTABLE BRONCHOSCOPE FB-15RBS · Class 2
All models of PENTAX (72)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This PENTAX FB-15RBS portable bronchoscope is a flexible scope used to look inside the lungs and airways. The 49 reports mostly describe the scope breaking, leaking fluid or blood, and having a loose biopsy port piece or a suction channel that clogs; a few mention a fuzzy or dead fiber image and a scope that sticks during use. Two reports describe airway obstruction in patients, and no deaths were reported. No recalls name this device.
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
- 49
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 04961333224081), received between Jul 24, 2021 and Jul 26, 2024 — classified as 2 injuries, 47 malfunctions.
The most frequently reported specific device problem is “Break” (19 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break19
- Fluid/Blood Leak15
- Loose or Intermittent Connection6
- Mechanical Problem2
- Obstruction of Flow2
- Physical Resistance/Sticking2
- Collapse1
- Component Missing1
Patient problems
- No Clinical Signs, Symptoms or Conditions47
- Airway Obstruction2
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 26, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. BIOPSY INLET PIECE LOOSENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19834815 ↗MalfunctionJun 4, 2024Obstruction of Flow; Obstruction of Flow
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. OPERATION/SUCTION CHANNEL CLOGGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19456481 ↗MalfunctionApr 16, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. BIOPSY INLET PIECE LOOSENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19113567 ↗MalfunctionMar 25, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18966682 ↗MalfunctionMar 15, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18909870 ↗MalfunctionMar 5, 2024Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18834119 ↗MalfunctionMar 5, 2024Break; Break
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18834105 ↗MalfunctionMar 5, 2024Obstruction of Flow; Obstruction of Flow
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. OPERATION/SUCTION CHANNEL CLOGGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18834101 ↗MalfunctionFeb 29, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. BIOPSY INLET PIECE LOOSENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18805187 ↗MalfunctionJan 24, 2024Break; Break
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18568184 ↗MalfunctionJan 19, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18540800 ↗MalfunctionDec 18, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18342411 ↗InjuryDec 12, 2023Mechanical Problem; Physical Resistance/Sticking; Mechanical Problem; Physical Resistance/Sticking
PENTAX MEDICAL WAS MADE AWARE OF AN EVENT ON 20-NOV-2023 THAT OCCURRED IN CHINA WITHIN THE APAC REGION IN THE OPERATING ROOM DURING USE. ON 22-OCT-2023, DURING A FIBEROPTIC BRONCHOSCOPY WITH SPUTUM ASPIRATION, THE ENDOSCOPE ENTERED INTO THE PATIENT'S AIRWAY VIA. THE TRACHEA CANNULA, AND WHEN THE ENDOSCOPE NEEDED TO HAVE THE LENS ROTATED, THE USER FOUND THAT THE ANGULATION CONTROL KNOB COULD NOT BE PRESSED UP AND DOWN, RESULTING IN THE BENDING PART OF DISTAL END BECOMING STUCK IN THE TRACHEA CANNULA. THE ENDOSCOPE COULD NOT BE WITHDRAWN SUCCESSFULLY WHICH RESULT IN THE PATIENT'S AIRWAY BEING RESTRICTED, AND THE PATIENT WAS IN RESPIRATORY DISTRESS WITH AN OBSTRUCTED VENTILATION TUBE. THE BALLOON WAS IMMEDIATELY DEFLATED AND THE TRACHEAL TUBE WAS REMOVED [ALONG WITH THE ENDOSCOPE], AND ONLY THE TRACHEAL TUBE WAS REINSERTED AND CONNECTED TO THE VENTILATOR TO ASSIST BREATHING. AFTER THAT, THE PATIENT'S BREATHING WAS STABLE AND VENTILATION WAS RESTORED, WITH OXYGEN SATURATION RETURNING TO NORMAL. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODU
Patient problems: Airway Obstruction
MAUDE report 18315413 ↗InjuryDec 12, 2023Mechanical Problem; Physical Resistance/Sticking; Mechanical Problem; Physical Resistance/Sticking
PENTAX MEDICAL WAS MADE AWARE OF AN EVENT ON 20-NOV-2023 THAT OCCURRED IN CHINA WITHIN THE APAC REGION IN THE OPERATING ROOM DURING USE. ON 22-OCT-2023, DURING A FIBEROPTIC BRONCHOSCOPY WITH SPUTUM ASPIRATION, THE ENDOSCOPE ENTERED INTO THE PATIENT'S AIRWAY VIA THE TRACHEA CANNULA, AND WHEN THE ENDOSCOPE NEEDED TO HAVE THE LENS ROTATED, THE USER FOUND THAT THE ANGULATION CONTROL KNOB COULD NOT BE PRESSED UP AND DOWN, RESULTING IN THE BENDING PART OF DISTAL END BECOMING STUCK IN THE TRACHEA CANNULA. THE ENDOSCOPE COULD NOT BE WITHDRAWN SUCCESSFULLY WHICH RESULT IN THE PATIENT'S AIRWAY BEING RESTRICTED, AND THE PATIENT WAS IN RESPIRATORY DISTRESS WITH AN OBSTRUCTED VENTILATION TUBE. THE BALLOON WAS IMMEDIATELY DEFLATED AND THE TRACHEAL TUBE WAS REMOVED [ALONG WITH THE ENDOSCOPE], AND ONLY THE TRACHEAL TUBE WAS REINSERTED AND CONNECTED TO THE VENTILATOR TO ASSIST BREATHING. AFTER THAT, THE PATIENT'S BREATHING WAS STABLE AND VENTILATION WAS RESTORED, WITH OXYGEN SATURATION RETURNING TO NORMAL. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUC
Patient problems: Airway Obstruction
MAUDE report 18314400 ↗MalfunctionNov 29, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18224619 ↗MalfunctionOct 17, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17947427 ↗MalfunctionOct 5, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17874096 ↗MalfunctionSep 29, 2023Break; Break
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17841412 ↗MalfunctionSep 20, 2023Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17778422 ↗MalfunctionSep 4, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE (FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17680591 ↗MalfunctionJul 26, 2023Break; No Display/Image; Break; No Display/Image
THE BATTERY COLD LIGHT SOURCE MIGHT BREAK AT THE CONNECTION WITH THE PROCESSOR DUE TO IMPROPER FORCE WHEN EXAMINING THE PATIENT. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17402085 ↗MalfunctionJun 12, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17104648 ↗MalfunctionApr 30, 2023Loose or Intermittent Connection; Loose or Intermittent Connection
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. BIOPSY INLET PIECE LOOSENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16841474 ↗MalfunctionApr 27, 2023Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16828686 ↗MalfunctionApr 4, 2023Break; Break
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16671597 ↗
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
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page