PENTAX EG29-i10 (UDI 04961333223909)Recalls & reported problems
Hoya Corporation · PENTAX VIDEO UPPER G.I.SCOPE EG29-i10 · Class 2
All models of PENTAX (72)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Pentax upper GI scope has 130 adverse event reports on record, with no deaths and no injuries. The reports mostly describe video image failures, such as blackouts or cloudy images, and some mention parts coming loose, clogged air or water channels, or leaks. Reports note no patient harm. There are no recalls naming this device. No reports came in the last 12 months, compared with 12 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
- 130
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 130 adverse event reports that list this exact device (DI 04961333223909), received between Sep 8, 2021 and Mar 3, 2025 — classified as 130 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (37 reports).
2 other recalls cover devices cleared under the same FDA submission (K131902); they may or may not involve this specific model.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component37
- Break34
- Obstruction of Flow22
- Fluid/Blood Leak14
- No Display/Image8
- Optical Distortion8
- Component Missing2
- Erratic or Intermittent Display2
Patient problems
- No Clinical Signs, Symptoms or Conditions130
Recent adverse event reports
The 25 most recent of 130 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 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 21501502 ↗MalfunctionFeb 20, 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 21418061 ↗MalfunctionFeb 13, 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 21371301 ↗MalfunctionFeb 5, 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 21309852 ↗MalfunctionFeb 5, 2025Obstruction of Flow; Obstruction of Flow
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER TUBE CLOGGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21309749 ↗MalfunctionJan 28, 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 21249497 ↗MalfunctionJan 16, 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 21164892 ↗MalfunctionJan 7, 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 21088542 ↗MalfunctionNov 27, 2024Obstruction of Flow; Obstruction of Flow
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER TUBE CLOGGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20793920 ↗MalfunctionNov 25, 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 20769023 ↗MalfunctionNov 20, 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 20731231 ↗MalfunctionNov 7, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. INSERTION FLEXIBLE TUBE (IFT) STEEL BRAID PIERCING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20627709 ↗MalfunctionOct 28, 2024Optical Obstruction; Optical 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 20542270 ↗MalfunctionOct 25, 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 20530448 ↗MalfunctionOct 10, 2024Obstruction of Flow; Obstruction of Flow
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER TUBE CLOGGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20414449 ↗MalfunctionOct 10, 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 20414444 ↗MalfunctionOct 10, 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 20414398 ↗MalfunctionOct 3, 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 20356976 ↗MalfunctionOct 3, 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 20356965 ↗MalfunctionOct 3, 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 20356882 ↗MalfunctionSep 20, 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 20264715 ↗MalfunctionSep 19, 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 20254396 ↗MalfunctionSep 10, 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 20178190 ↗MalfunctionAug 26, 2024No Display/Image; No Display/Image
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 20062369 ↗MalfunctionAug 23, 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 20051568 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K131902. One submission often covers many models, so check the product and lot details in each record.
- Z-0318-2017 · Aug 15, 2016 · TerminatedPentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy Device such as a Biopsy Forcep
- Z-2071-2016 · Apr 6, 2016 · TerminatedGastroscope Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, ti
Other Gastroscope and accessories, flexible/rigid devices
- PENTAX Medical EG29-i10cHoya Corporation · Gastroscope And Accessories, Flexible/Rigid1,623 reports
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1TH190Olympus Medical Systems Corp. · Gastroscope And Accessories, Flexible/Rigid4 recalls6 deaths1,025 reports
- EVIS EXERA lll GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-XP190NOlympus Medical Systems Corp. · Gastroscope and accessories, flexible/rigid1 recall559 reports
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GIF-Q165Olympus Medical Systems Corp. · Gastroscope and accessories, flexible/rigid349 reports
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE H180Olympus Medical Systems Corp. · Gastroscope and accessories, flexible/rigid1 death302 reports
- PENTAX EG27-i10Hoya Corporation · Gastroscope and accessories, flexible/rigid261 reports
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180ALOlympus Medical Systems Corp. · Gastroscope and accessories, flexible/rigid2 deaths252 reports
- BALLOON MAJ-1351Olympus Medical Systems Corp. · Gastroscope and accessories, flexible/rigid174 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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