PENTAX Medical EG36-J10UR (UDI 04961333239597)Recalls & reported problems

Hoya Corporation · PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This PENTAX ultrasound endoscope is a flexible scope used to view the upper digestive tract with ultrasound. All 127 reports are malfunctions, with no injuries or deaths; some describe blocked channels, loose parts or fluid leaks, and others describe video failures such as blackouts. 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: 126
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 04961333239597), received between Jul 2, 2021 and Jul 29, 2026 — classified as 126 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (34 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

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

Most reported problems

Device problems

Obstruction of Flow34
Detachment of Device or Device Component22
Fluid/Blood Leak20
Break17
No Display/Image13
Erratic or Intermittent Display5
Optical Obstruction5
Unintended Movement4

Patient problems

No Clinical Signs, Symptoms or Conditions125
Insufficient Information2

Recent adverse event reports

The 25 most recent of 126 reports, in the reporter's own words as published by the FDA.

MalfunctionJul 29, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50064960 ↗
MalfunctionApr 6, 2026Detachment of Device or Device Component
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER NOZZLE PEELED OFF (BLACK GLUE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24787270 ↗
MalfunctionMar 23, 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 24659321 ↗
MalfunctionFeb 25, 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 24438867 ↗
MalfunctionDec 26, 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 23894596 ↗
MalfunctionJul 15, 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 22503958 ↗
MalfunctionJun 24, 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 22312972 ↗
MalfunctionJun 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER NOZZLE PEELED OFF (BLACK GLUE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22216875 ↗
MalfunctionApr 3, 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 21759508 ↗
MalfunctionJan 14, 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 21146554 ↗
MalfunctionNov 29, 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 20808443 ↗
MalfunctionSep 24, 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 20289401 ↗
MalfunctionJul 24, 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 19813631 ↗
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 19813521 ↗
MalfunctionJun 26, 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 19612521 ↗
MalfunctionJun 21, 2024Optical Obstruction; Optical Obstruction
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE (SHADOW IN IMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19581975 ↗
MalfunctionJun 14, 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. AIR/WATER NOZZLE PEELED OFF (BLACK GLUE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19534972 ↗
MalfunctionJun 12, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
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 19517233 ↗
MalfunctionJun 6, 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 19474569 ↗
MalfunctionMay 16, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
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 19328668 ↗
MalfunctionMay 16, 2024Obstruction of Flow; Obstruction of Flow
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER TUBE CLOGGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19328186 ↗
MalfunctionMay 16, 2024Obstruction of Flow; Obstruction of Flow
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER TUBE CLOGGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19327978 ↗
MalfunctionMay 10, 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 19283460 ↗
MalfunctionMay 8, 2024Obstruction of Flow; Obstruction of Flow
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER TUBE CLOGGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19266074 ↗
MalfunctionMay 1, 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 19218753 ↗

Device details

UDI-DI	`04961333239597`
Brand	PENTAX Medical
Model	EG36-J10UR
Company	Hoya Corporation
Product code	ODG · Endoscopic Ultrasound System, Gastroenterology-Urology
Class	Class 2
FDA submission	None listed
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	Nov 18, 2024

Device type (GMDN): Flexible ultrasound gastroduodenoscope

An endoscope with a flexible inserted portion, combined with an ultrasound probe, intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct]. It is inserted into the body through the mouth during gastroduodenoscopy. Anatomical images are transmitted to the user through a fibreoptic bundle or a video system and the ultrasound probe. The probe may be built-in, or inserted through a dedicated lumen. This device is commonly used to examine structures of the stomach, duodenum, pancreas, and bile duct. This is a reusable device.

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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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