PENTAX EC34-i10L (UDI 04961333225811)Recalls & reported problems
Hoya Corporation · PENTAX VIDEO COLONOSCOPE EC34-i10 SERIES · Class 2
All models of PENTAX (72)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Pentax video colonoscope is a flexible endoscope used to examine the colon. Many of the 844 reports describe parts breaking or detaching, display or image failures, optical blockages and fluid leaks. The reports include 4 injuries and no deaths. 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
- 848
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 848 adverse event reports that list this exact device (DI 04961333225811), received between Aug 6, 2020 and Sep 30, 2026 — classified as 4 injuries, 844 malfunctions.
The most frequently reported specific device problem is “Break” (181 reports).
6 other recalls cover devices cleared under the same FDA submission (K131855); 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break181
- Detachment of Device or Device Component117
- Erratic or Intermittent Display115
- No Display/Image107
- Optical Obstruction95
- Fluid/Blood Leak88
- Obstruction of Flow74
- Optical Distortion25
Patient problems
- No Clinical Signs, Symptoms or Conditions837
- Insufficient Information16
- No Known Impact Or Consequence To Patient5
- Device Embedded In Tissue or Plaque3
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 848 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 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 50942352 ↗MalfunctionSep 2, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50558340 ↗MalfunctionSep 2, 2026Optical Obstruction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50558333 ↗MalfunctionSep 1, 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 50536429 ↗MalfunctionAug 18, 2026Optical Obstruction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50292713 ↗MalfunctionAug 13, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50232166 ↗MalfunctionAug 13, 2026Optical Obstruction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50232159 ↗MalfunctionAug 10, 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 50189580 ↗MalfunctionAug 10, 2026Detachment 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 50189571 ↗MalfunctionAug 7, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50170885 ↗MalfunctionAug 3, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50111526 ↗MalfunctionJul 13, 2026Optical Obstruction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25791977 ↗MalfunctionJul 13, 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 25791975 ↗MalfunctionJul 2, 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 25686785 ↗MalfunctionMay 29, 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 25326956 ↗MalfunctionMay 25, 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 25267461 ↗MalfunctionMay 20, 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 25225935 ↗MalfunctionMay 19, 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 25212140 ↗MalfunctionMay 18, 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 25197196 ↗MalfunctionMay 12, 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 25146012 ↗MalfunctionMay 1, 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 25054097 ↗MalfunctionApr 17, 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 24906596 ↗MalfunctionApr 3, 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 24780816 ↗MalfunctionMar 13, 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 24587744 ↗MalfunctionMar 9, 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 24542420 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K131855. One submission often covers many models, so check the product and lot details in each record.
- Z-2449-2021 · Jul 14, 2021 · Open, ClassifiedGastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Chan
- Z-2448-2021 · Jul 14, 2021 · Open, ClassifiedColonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC
- Z-1268-2020 · Jan 3, 2020 · TerminatedPentax Video Colonoscope Model: EC38-i10L
- Z-1267-2020 · Jan 3, 2020 · TerminatedPentax Video Colonoscope Model: EC34-i10L
- Z-0636-2017 · Aug 15, 2016 · TerminatedPentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, EndoTherapy Device such as a Biopsy Forcep
- Z-2068-2016 · Apr 6, 2016 · TerminatedColonoscope Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, ti
Other Colonoscope and accessories, flexible/rigid devices
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-HQ190LOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2 deaths6,804 reports
- EVIS EXERA III XENON LIGHT SOURCE OLYMPUS CLV-190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid6,617 reports
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-HQ190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls5 deaths6,244 reports
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-H190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid2 recalls7 deaths5,572 reports
- EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190DLOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2,830 reports
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS PCF-H190LOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2 deaths2,513 reports
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-H190IOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid1 recall1,967 reports
- PENTAX Medical EC38-i10cLHoya Corporation · Colonoscope and accessories, flexible/rigid1,618 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.
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