PENTAX Medical EG29-i10c (UDI 04961333247387)Recalls & reported problems
Hoya Corporation · PENTAX Medical Video Upper GI Scope EG29-i10c · Class 2
All models of PENTAX Medical (34)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is the Pentax video upper GI scope, a flexible endoscope used to look inside the stomach. The 1,633 reports often describe blocked or distorted camera images, fluid or blood leaking into the scope, and parts breaking. Some mention a clogged suction channel. The records include no deaths, 2 injuries and 1,631 malfunctions, and no recalls name this device. Reports fell to 46 in the last 12 months from 86 in the 12 months before.
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
- 1,623
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,623 adverse event reports that list this exact device (DI 04961333247387), received between Jul 28, 2021 and Jul 13, 2026 — classified as 2 injuries, 1,621 malfunctions.
The most frequently reported specific device problem is “Optical Obstruction” (406 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
- Optical Obstruction406
- Fluid/Blood Leak335
- Break313
- Erratic or Intermittent Display157
- Optical Distortion154
- Obstruction of Flow117
- No Display/Image92
- Unintended Movement29
Patient problems
- No Clinical Signs, Symptoms or Conditions1,619
- Insufficient Information6
- Foreign Body In Patient2
Recent adverse event reports
The 25 most recent of 1,623 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 13, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25791979 ↗MalfunctionJul 1, 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 25675214 ↗MalfunctionJun 9, 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 25439756 ↗MalfunctionJun 2, 2026Optical 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 25356773 ↗MalfunctionMay 21, 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 25237980 ↗MalfunctionMay 19, 2026Fluid/Blood Leak
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 25212151 ↗MalfunctionMay 14, 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 25167864 ↗MalfunctionMay 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 25146003 ↗MalfunctionMay 7, 2026Optical 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 25108337 ↗MalfunctionMay 7, 2026Poor Quality 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 25108326 ↗MalfunctionApr 15, 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 24880678 ↗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 24880676 ↗MalfunctionApr 6, 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 24787277 ↗MalfunctionApr 3, 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 24772958 ↗MalfunctionMar 30, 2026Fluid/Blood Leak
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 24724891 ↗MalfunctionMar 30, 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 24724774 ↗MalfunctionMar 24, 2026Optical 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 24678804 ↗MalfunctionMar 23, 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 24659312 ↗MalfunctionFeb 20, 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 24398082 ↗MalfunctionFeb 9, 2026Poor Quality 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 24288761 ↗MalfunctionFeb 9, 2026Optical 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 24288731 ↗MalfunctionJan 30, 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 24219010 ↗MalfunctionJan 27, 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 24186258 ↗MalfunctionJan 27, 2026Optical 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 24186253 ↗MalfunctionJan 27, 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 24186243 ↗
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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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