PENTAX Medical EG38-J10UTRecalls & reported problems
Hoya Corporation · PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT · Class 2
All models of PENTAX Medical (34)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Pentax Medical upper GI ultrasound video scope is an endoscope used to image the upper digestive tract. All 292 reports are malfunction reports, and many describe leaks, parts breaking, blocked flow, and the image going blank, flickering or showing shadows. The reports include no deaths and no injuries. 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
- 295
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 295 adverse event reports that list this exact device (DI 04961333239498), received between Jul 2, 2021 and Sep 25, 2026 — classified as 295 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (64 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
- Fluid/Blood Leak64
- Break61
- Obstruction of Flow42
- No Display/Image35
- Erratic or Intermittent Display31
- Optical Obstruction24
- Detachment of Device or Device Component12
- Optical Distortion7
Patient problems
- No Clinical Signs, Symptoms or Conditions293
- Insufficient Information6
Recent adverse event reports
The 25 most recent of 295 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Erratic 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 50893615 ↗MalfunctionSep 24, 2026Fluid/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 50877469 ↗MalfunctionSep 18, 2026Erratic 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 50813597 ↗MalfunctionSep 8, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50661474 ↗MalfunctionAug 24, 2026Fluid/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 50400858 ↗MalfunctionAug 17, 2026Optical Obstruction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50269329 ↗MalfunctionAug 7, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50170873 ↗MalfunctionAug 3, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50111535 ↗MalfunctionJul 30, 2026Optical Obstruction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50079003 ↗MalfunctionJul 21, 2026Optical Obstruction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25884948 ↗MalfunctionJul 17, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25851043 ↗MalfunctionJun 19, 2026Fluid/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 25557093 ↗MalfunctionMay 18, 2026Optical Obstruction
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(SHADOW IN IMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25197186 ↗MalfunctionApr 15, 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 24880670 ↗MalfunctionApr 13, 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 24854182 ↗MalfunctionApr 8, 2026Fluid/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 24812447 ↗MalfunctionApr 3, 2026Break
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 24772970 ↗MalfunctionApr 3, 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 24772968 ↗MalfunctionMar 30, 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 24725175 ↗MalfunctionMar 24, 2026Break
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 24672143 ↗MalfunctionMar 19, 2026Fluid/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 24636015 ↗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 24504096 ↗MalfunctionFeb 24, 2026Fluid/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 24424840 ↗MalfunctionFeb 17, 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 24361014 ↗MalfunctionJan 30, 2026Optical Obstruction
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(SHADOW IN IMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24219020 ↗
Other Endoscopic Ultrasound System, Gastroenterology-Urology devices
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- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180Olympus Medical Systems Corp. · Endoscopic ultrasound system, gastroenterology-urology266 reports
- PENTAX EG-3870UTKHoya Corporation · Endoscopic ultrasound system, gastroenterology-urology164 reports
- PENTAX Medical EG36-J10URHoya Corporation · Endoscopic Ultrasound System, Gastroenterology-Urology126 reports
- PENTAX EG-3670URKHoya Corporation · Endoscopic ultrasound system, gastroenterology-urology72 reports
- PENTAX Medical EG34-J10UHoya Corporation · Endoscopic Ultrasound System, Gastroenterology-Urology61 reports
- BALLOON MAJ-1351Olympus Medical Systems Corp. · Endoscopic ultrasound system, gastroenterology-urology29 reports
- Acquire M00555540Boston Scientific Corporation · Endoscopic ultrasound system, gastroenterology-urology1 death18 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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