PENTAX EB-1970UKRecalls & reported problems
Hoya Corporation · PENTAX ULTRASOUND VIDEOBRONCHOSCOPE EB-1970UK · Class 2
All models of PENTAX (72)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Pentax EB-1970UK ultrasound bronchoscope is a flexible scope used to examine the airways and nearby tissue. Of its 90 reports, no deaths or injuries are recorded. Reports mostly describe fluid leaking into the scope, parts breaking, and video images going cloudy or blacking out. Most reports describe no clinical signs or impact on the patient. There were no reports in the last 12 months, down from 4 before. 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
- 90
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 04961333227112), received between Dec 31, 2020 and Mar 21, 2025 — classified as 90 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (35 reports).
4 other recalls cover devices cleared under the same FDA submission (K131946); 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak35
- Break21
- Loose or Intermittent Connection8
- Obstruction of Flow7
- Optical Obstruction7
- Optical Distortion3
- Physical Resistance/Sticking3
- Unintended Movement3
Patient problems
- No Clinical Signs, Symptoms or Conditions89
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 90 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 21, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21660676 ↗MalfunctionMar 3, 2025No Display/Image; No Display/Image
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE (BLACKOUT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21501526 ↗MalfunctionJan 6, 2025Obstruction of Flow; Obstruction of Flow
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER TUBE CLOGGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21076729 ↗MalfunctionNov 7, 2024Optical Obstruction; Optical Obstruction
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE (CLOUDY).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20627918 ↗MalfunctionOct 28, 2024No Display/Image; No Display/Image
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE BLACKOUT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20542167 ↗MalfunctionOct 15, 2024Optical Obstruction; Optical Obstruction
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE (CLOUDY).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20448313 ↗MalfunctionSep 24, 2024Optical Obstruction; Optical Obstruction
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(CLOUDY ).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20289347 ↗MalfunctionSep 17, 2024Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20234675 ↗MalfunctionSep 9, 2024Obstruction of Flow; Obstruction of Flow
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER TUBE CLOGGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20167208 ↗MalfunctionAug 7, 2024Optical Obstruction; Optical Obstruction
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(CLOUDY).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19926715 ↗MalfunctionApr 22, 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 19150242 ↗MalfunctionFeb 15, 2024Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement
CUSTOMER REPORTED THAT THE ULTRASOUND CRYSTALS APPEAR TO BE OFF TO ONE SIDE AND EBUS NEEDLES COMING OUT THE DISTAL TIP AT AN ODD ANGLE. NO INJURY OR DEATH INVOLVED. ONLY THE POTENTIAL TO DUE TO THE UNPREDICTABILITY OF THE ANGLE OF THE NEEDLE COMING OUT THE DISTAL TIP. 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 18717842 ↗MalfunctionJan 9, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18472453 ↗MalfunctionJul 14, 2023Erratic or Intermittent Display; Erratic or Intermittent Display
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17322831 ↗MalfunctionJun 9, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE (FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17095759 ↗MalfunctionMay 29, 2023Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(OBJECTIVE LENS BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17016257 ↗MalfunctionMay 1, 2023Loose or Intermittent Connection; Loose or Intermittent Connection
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. SUCTION NIPPLE LOOSENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16841918 ↗MalfunctionApr 21, 2023Optical Obstruction; Optical Obstruction
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(CLOUDY ).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16782538 ↗MalfunctionApr 14, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE (FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16741478 ↗MalfunctionMar 30, 2023Optical Obstruction; Optical Obstruction
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(CLOUDY).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16641101 ↗MalfunctionJan 18, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16193457 ↗MalfunctionJan 10, 2023Optical Distortion; Optical Distortion
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE (CLOUDY).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16128849 ↗MalfunctionDec 20, 2022Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16011559 ↗MalfunctionDec 16, 2022Optical Obstruction; Optical Obstruction
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE (CLOUDY).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15993479 ↗MalfunctionDec 7, 2022Optical Distortion; Optical Distortion
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE (CLOUDY).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15929684 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K131946. One submission often covers many models, so check the product and lot details in each record.
- Z-0757-2017 · May 31, 2016 · TerminatedUltrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to
- Z-2324-2017 · Jan 11, 2011 · TerminatedVideo Bronchoscope
- Z-2326-2017 · Jan 11, 2011 · TerminatedVideo Naso pharyngo Laryngoscopes
- Z-2325-2017 · Jan 11, 2011 · TerminatedVideo Cytoscopes
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.
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