PENTAX EB-1575KRecalls & reported problems

Hoya Corporation · PENTAX VIDEO BRONCHOSCOPE EB-1575K · Class 2

All models of PENTAX (72)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This PENTAX EB-1575K video bronchoscope is a flexible scope used to look inside the airways and lungs. Reports mostly describe the picture going black or cutting out, the shaft breaking, and fluid or blood leaking inside the scope; one report describes the scope getting stuck in a patient's trachea and damaging both the scope and the trach. There are 43 reports, with 4 injuries and no deaths, and 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: 43
Deaths reported: 0
Injuries reported: 4
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 04961333226818), received between Feb 26, 2020 and Apr 8, 2026 — classified as 4 injuries, 39 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (13 reports).

6 other recalls cover devices cleared under the same FDA submission (K131028); 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

No Display/Image13
Break11
Fluid/Blood Leak6
Erratic or Intermittent Display2
Failure to Disconnect2
Insufficient Device Problem Information2
Obstruction of Flow2
Physical Resistance/Sticking2

Patient problems

No Clinical Signs, Symptoms or Conditions40
Insufficient Information3
Viral Infection2

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 8, 2026No 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 24812454 ↗
MalfunctionMar 4, 2026No 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 24510435 ↗
MalfunctionMar 24, 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 21674701 ↗
MalfunctionMar 11, 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 21569665 ↗
MalfunctionNov 27, 2024No 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 20794155 ↗
MalfunctionNov 7, 2024No 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 20627702 ↗
InjuryMay 1, 2024Use of Device Problem; Unintended Movement; Use of Device Problem; Unintended Movement
ON 04-APR-2024, PENTAX MEDICAL INITIALLY BECAME AWARE OF AN EVENT WHEN THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE PULMONOLOGIST COULD NOT ADVANCE THE ENDOSCOPE AFTER INSERTING THROUGH TRACH PATIENT. WHEN PULLING BACK, THE ENDOSCOPE CAUGHT ON PATIENT TRACH, DAMAGING THE ENDOSCOPE. THE USER WAS UNABLE TO REMOVE THE ENDOSCOPE FROM THE TRACH WITHOUT REMOVING TRACH AS WELL. THE PATIENT WAS STABILIZED, THE ENDOSCOPE AND TRACH REMOVED, AND A NEW TRACH WAS PLACED. PLEASE REFER TO SECTION H11 FOR GOOD FAITH EFFORT DETAILS CLARIFYING THAT THE USER CLARIFIED THAT THE ENDOSCOPE WAS CAUGHT ON A TRACHEOSTOMY TUBE AND NOT THE PATIENT'S TRACHEA. 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 19226976 ↗
InjuryMay 1, 2024Unintended Movement; Unintended Movement
REFER TO H11.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19221467 ↗
MalfunctionMar 12, 2024No 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 18883517 ↗
MalfunctionMar 12, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
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 18883301 ↗
MalfunctionFeb 14, 2024Erratic 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 18700770 ↗
MalfunctionNov 14, 2023No 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 18128338 ↗
MalfunctionSep 27, 2023No 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 17822617 ↗
MalfunctionSep 26, 2023No 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 17815029 ↗
MalfunctionMar 20, 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 16571120 ↗
MalfunctionJan 23, 2023Fluid/Blood Leak; Fluid/Blood Leak
1.24 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 16231092 ↗
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 16192274 ↗
MalfunctionJan 10, 2023Break; Break
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 16128881 ↗
MalfunctionDec 15, 2022Obstruction 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 15984403 ↗
MalfunctionNov 24, 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 15860100 ↗
MalfunctionNov 11, 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 15777621 ↗
MalfunctionOct 14, 2022Fluid/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 15603120 ↗
MalfunctionAug 29, 2022Break; Break
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 15308468 ↗
MalfunctionAug 19, 2022Fluid/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 15256498 ↗
MalfunctionJun 30, 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 14869322 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131028. One submission often covers many models, so check the product and lot details in each record.

Z-2875-2016 · May 31, 2016 · Terminated
Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as bio
Z-2076-2016 · Apr 6, 2016 · Terminated
Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Pulmonary Tract including but not restricted to org
Z-2065-2016 · Apr 6, 2016 · Terminated
Bronchoscope Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes, but is not restricted to, the organs, tiss
Z-2326-2017 · Jan 11, 2011 · Terminated
Video Naso pharyngo Laryngoscopes
Z-2325-2017 · Jan 11, 2011 · Terminated
Video Cytoscopes
Z-2324-2017 · Jan 11, 2011 · Terminated
Video Bronchoscope

Device details

UDI-DI	`04961333226818`
Brand	PENTAX
Model	EB-1575K
Company	Hoya Corporation
Product code	EOQ · BRONCHOSCOPE (FLEXIBLE OR RIGID)
Class	Class 2
FDA submission	K131028
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 7, 2025

Device type (GMDN): Flexible video bronchoscope, reusable

An endoscope with a flexible inserted portion intended for endoscopic procedures of the airways and tracheobronchial tree (i.e., bronchoscopy). It typically consists of a handle portion and an insertion tube which includes working channels and a distal camera from which anatomical images are transmitted and displayed on a monitor (video bronchoscopy). It is typically intended for flexible optical intubation, airway inspection, and may be used to assist in other diagnostic or therapeutic procedures [e.g., bronchoalveolar lavage (BAL)]. This is a reusable device.

Other BRONCHOSCOPE (FLEXIBLE OR RIGID) devices

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190
Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)
3 recalls5 deaths1,557 reports
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190
Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)
4 recalls1 death1,214 reports
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XP190
Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)
4 recalls1,146 reports
Ion 380748
Intuitive Surgical, Inc. · Bronchoscope (flexible or rigid)
1 recall97 deaths1,278 reports
VISERA ELITE XENON LIGHT SOURCE OLYMPUS CLV-S190
Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)
1,155 reports
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190
Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)
5 recalls3 deaths621 reports
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190
Olympus Medical Systems Corp. · Bronchoscope (Flexible Or Rigid)
3 recalls333 reports
BRONCHOVIDEOSCOPE BF-1T150
Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)
4 recalls212 reports

All BRONCHOSCOPE (FLEXIBLE OR RIGID) devices →

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