PENTAX Medical EG29-i10c (UDI 04961333248483)Recalls & reported problems
Hoya Corporation · PENTAX Medical Video Upper GI Scope EG29-i10c (Made in Malaysia) · Class 2
All models of PENTAX Medical (34)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Pentax upper GI video scope is an endoscope used to look inside the upper digestive tract. The FDA records hold 96 reports, with no deaths and no injuries; many describe video image failures such as blackouts or cloudy images, and some describe fluid damage. 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
- 95
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 04961333248483), received between Jul 1, 2021 and May 8, 2026 — classified as 95 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (15 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
- Poor Quality Image15
- Optical Distortion14
- Fluid/Blood Leak13
- Loss of or Failure to Bond12
- Improper or Incorrect Procedure or Method10
- Electrical Overstress7
- Leak/Splash6
- Moisture or Humidity Problem6
Patient problems
- No Clinical Signs, Symptoms or Conditions94
- Insufficient Information4
Recent adverse event reports
The 25 most recent of 95 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 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 25120208 ↗MalfunctionApr 6, 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 24787279 ↗MalfunctionMar 11, 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 24565972 ↗MalfunctionJan 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 23986886 ↗MalfunctionJul 23, 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 22573321 ↗MalfunctionJul 15, 2025Poor Quality Image; Poor 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 22503977 ↗MalfunctionJul 14, 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 22491555 ↗MalfunctionJun 9, 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 MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164901 ↗MalfunctionJun 2, 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 22121421 ↗MalfunctionMay 21, 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 22058205 ↗MalfunctionMar 3, 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 21501549 ↗MalfunctionFeb 6, 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 21318885 ↗MalfunctionOct 3, 2024Optical 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 20356865 ↗MalfunctionSep 24, 2024Erratic 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 20289356 ↗MalfunctionSep 10, 2024Optical 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 20178206 ↗MalfunctionAug 28, 2021Fluid/Blood Leak; Fluid/Blood Leak
PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT WHICH OCCURRED IN THE EMEA REGION DURING INSPECTION IN THE WORKSHOP WITH THE REPORTING "THE ELECTRICAL CONNECTING PINS ON THE LG-PLUG ARE LEAKY. ELECTRICAL SAFETY TEST FAILED." INVOLVING PENTAX MEDICAL VIDEO GASTROSCOPE MODEL EG29-I10C, SERIAL NUMBER (B)(4). THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR OTHER SIGNIFICANT/IMPORTANT MEDICAL EVENT. THE DEFECTIVE PARTS WILL BE REPLACED AS PART OF THE SERVICE REQUEST. THIS EVENT IS FDA REPORTABLE DUE TO THE LACK OF INFORMATION TO JUSTIFY THAT THIS EVENT WOULD NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR OTHER ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12381165 ↗MalfunctionAug 27, 2021Fluid/Blood Leak; Poor Quality Image; Electrical Overstress; Fluid/Blood Leak; Poor Quality Image; Electrical Overstress
MEDICAL WAS MADE AWARE OF THE FOLLOWING COMPLAINT THAT OCCURRED IN THE EMEA REGION. (B)(6) FOUND MANY BLACK DOTS IN THE IMAGE AND WHEN INSPECTED IN THE WORKSHOP THE ELECTRICAL SAFETY TEST FAIL AND THEY FOUND A LEAKY TUBE INVOLVING PENTAX MEDICAL VIDEO GASTROSCOPE MODEL EG29-I10C, SERIAL NUMBER (B)(4). THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR OTHER SIGNIFICANT/ IMPORTANT MEDICAL EVENT. THE ENDOSCOPE WILL BE REPAIRED AS PART OF THE SERVICE REPAIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12379819 ↗MalfunctionAug 21, 2021Loss of or Failure to Bond; Improper or Incorrect Procedure or Method; Loss of or Failure to Bond; Improper or Incorrect Procedure or Method
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. ELECTRICAL SAFETY TEST FAIL. DETECTED AT INCOMING INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12351829 ↗MalfunctionAug 21, 2021Electrical /Electronic Property Problem; Optical Distortion; Electrical /Electronic Property Problem; Optical Distortion
THIS EVENT OCCURRED AT THE TIME OF DURING INSPECTION. THERE WAS NO REPORT OF PATIENT HARM. ISO FAILED ; MISTY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12351828 ↗MalfunctionAug 21, 2021Loss of or Failure to Bond; Improper or Incorrect Procedure or Method; Loss of or Failure to Bond; Improper or Incorrect Procedure or Method
THIS EVENT OCCURRED AT THE TIME OF DURING INSPECTION. THERE WAS NO REPORT OF PATIENT HARM. DIELECTRIC STRENGTH TEST FAILED. DETECTED AT INCOMING INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12351827 ↗MalfunctionAug 21, 2021Loss of or Failure to Bond; Improper or Incorrect Procedure or Method; Loss of or Failure to Bond; Improper or Incorrect Procedure or Method
THIS EVENT OCCURRED AT THE TIME OF DURING INSPECTION. THERE WAS NO REPORT OF PATIENT HARM. ISOLATION TEST - FAILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12351825 ↗MalfunctionAug 21, 2021Electrical /Electronic Property Problem; Optical Distortion; Material Split, Cut or Torn; Electrical /Electronic Property Problem; Optical Distortion; Material Split, Cut or Torn
THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. ISO FAILED, MISTY IMAGE, LED COVER GLASS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12351824 ↗MalfunctionAug 21, 2021Loss of or Failure to Bond; Break; Improper or Incorrect Procedure or Method; Loss of or Failure to Bond; Break; Improper or Incorrect Procedure or Method
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. OBJECTIVE LENS BROKEN. ELECTRICAL SAFETY TEST FAILED (DETECTED AT WORKSHOP INSPECTION).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12351823 ↗MalfunctionAug 21, 2021Loss of or Failure to Bond; Improper or Incorrect Procedure or Method; Loss of or Failure to Bond; Improper or Incorrect Procedure or Method
THIS EVENT OCCURRED DURING INSPECTION. THERE WAS NO REPORT OF PATIENT HARM. ELECTRICAL SAFETY TEST FAIL. DETECTED AT INCOMING INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12351822 ↗MalfunctionAug 21, 2021Loss of or Failure to Bond; Improper or Incorrect Procedure or Method; Loss of or Failure to Bond; Improper or Incorrect Procedure or Method
THIS EVEN OCCURRED DURING INSPECTION. THERE WAS NO REPORT OF PATIENT HARM. ELECTRICAL SAFETY TEST FAILED, FOUND DURING THE INCOMING INSPECTION BY VARIMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12351820 ↗
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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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