PENTAX Medical EG36-J10UR (UDI 04961333248933)Recalls & reported problems
Hoya Corporation · PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR (Made in Malaysia) · Class 2
All models of PENTAX Medical (34)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04961333248933), received between Sep 12, 2024 and Jul 16, 2026 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 Leak4
- Optical Obstruction3
- Detachment of Device or Device Component2
- Delivered as Unsterile Product1
- Erratic or Intermittent Display1
- No Display/Image1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25834794 ↗MalfunctionMay 20, 2026Detachment 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 25225924 ↗MalfunctionMay 20, 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 25225902 ↗MalfunctionApr 23, 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 24961736 ↗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 24424837 ↗MalfunctionFeb 12, 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 24319852 ↗MalfunctionJul 9, 2025Optical 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 22454899 ↗MalfunctionApr 24, 2025No 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 21896930 ↗MalfunctionMar 26, 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 21694903 ↗MalfunctionJan 7, 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 21088535 ↗MalfunctionOct 31, 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 20575841 ↗MalfunctionSep 12, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
B3:NOT KNOWN FOR THE EXACT DATE, WE JUST KNOW THE YEAR THE COMPLAINT WAS SENT IN TO MANUFACTURER. BASED ON THE INITIAL REPORT, 3 NEW EUS SCOPES HAVE EXPIRED BALLOONS IN THEIR BOX. DESCRIPTION OF ANY ACTIONS TAKEN: SUBMITTED REQUEST TO MAKE SURE WHEN EUS SCOPES ARE SENT OUT, BALLOONS ARE NOT EXPIRED. THIS EVENT OCCURRED AT THE TIME OF DURING INSTALLATION. 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 20208997 ↗
Other Endoscopic Ultrasound System, Gastroenterology-Urology devices
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180Olympus Medical Systems Corp. · Endoscopic ultrasound system, gastroenterology-urology5 deaths2,392 reports
- PENTAX Medical EG38-J10UTHoya Corporation · Endoscopic Ultrasound System, Gastroenterology-Urology295 reports
- 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
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.
How reports and recalls are matched · Editorial policy · Report an error on this page