PENTAX Medical EB15-J10Recalls & reported problems
Hoya Corporation · PENTAX Medical Video Bronchoscope EB15-J10 · Class 2
All models of PENTAX Medical (34)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04961333225453), received between Jul 20, 2021 and Sep 8, 2026 — classified as 20 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (9 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- No Display/Image9
- Erratic or Intermittent Display2
- Fluid/Blood Leak2
- Optical Obstruction2
- Break1
- Detachment of Device or Device Component1
- Gas/Air Leak1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Insufficient Information1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50661480 ↗MalfunctionMar 16, 2026Obstruction 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 24602420 ↗MalfunctionDec 19, 2025Erratic 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 23847031 ↗MalfunctionDec 10, 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 23765015 ↗MalfunctionJul 8, 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 22432873 ↗MalfunctionJul 8, 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 22432847 ↗MalfunctionMay 19, 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 22041604 ↗MalfunctionMay 2, 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 21947639 ↗MalfunctionJul 25, 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 19824038 ↗MalfunctionJul 24, 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 19813801 ↗MalfunctionJul 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. BENDING RUBBER PEELED OFF(BLACK GLUE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19673055 ↗MalfunctionJun 11, 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 19507883 ↗MalfunctionJan 31, 2024Optical Obstruction; Optical Obstruction
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 18611881 ↗MalfunctionOct 9, 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 17902234 ↗MalfunctionJun 7, 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 17076723 ↗MalfunctionMay 24, 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 16990284 ↗MalfunctionMay 16, 2023Break; Break
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16937252 ↗MalfunctionMar 31, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16653571 ↗MalfunctionAug 11, 2021Poor Quality Image; Material Deformation; Poor Quality Image; Material Deformation
PENTAX MEDICAL (B)(6) SERVICE WORKSHOP INSPECTED PENTAX MODEL EB15-J10/SERIAL (B)(4) AND CONFIRMED THE FOLLOWING: DISTAL BODY DEFORMED, LEAKY. SPOT IN THE IMAGE. IFT AND SEGMENTS SQUEEZED. THE CUSTOMER COMPLAINT WAS NOT STATED. SERVICE STATED THE DEFECTS WERE CAUSED BY EXTERNAL FORCE. THE DEVICE IS PENDING REPAIRS. 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: Insufficient Information
MAUDE report 12306911 ↗MalfunctionJul 20, 2021Gas/Air Leak; Gas/Air Leak
LEAK OF THE PVE CONNECTOR AT FIRST USE. WITHOUT ANY USE AND DURING THE FIRST REPROCESSING BEFORE SAMPLING, USERS NOTICED A SIGNIFICANT LEAK ON THE PVE CONNECTOR. IT HAS NOT BEEN DETECTED WITH SHA-P6. THE INTENSITY IS AN AIR BUBBLE EACH 3 SECONDS AND IT IS LOCATED AT THE JUNCTION BETWEEN THE LG CABLE CONNECTOR ASS'Y AND THE HOUSING. THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12194404 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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