PENTAX EC38-i10L (UDI 04961333223060)Recalls & reported problems
Hoya Corporation · PENTAX VIDEO COLONOSCOPE EC38-i10 SERIES · Class 2
All models of PENTAX (72)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Pentax video colonoscope has 212 adverse event reports, with no deaths or injuries. Many describe parts breaking or peeling off the scope, blacked-out or shadowed video images, and fluid leaks. No patient harm is reported in these entries. 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
- 212
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 212 adverse event reports that list this exact device (DI 04961333223060), received between Nov 2, 2020 and Mar 3, 2025 — classified as 212 malfunctions.
The most frequently reported specific device problem is “Break” (66 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break66
- Detachment of Device or Device Component43
- Optical Distortion22
- Fluid/Blood Leak20
- Obstruction of Flow20
- No Display/Image16
- Optical Obstruction12
- Erratic or Intermittent Display8
Patient problems
- No Clinical Signs, Symptoms or Conditions212
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 212 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 (SHADOW IN IMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21501462 ↗MalfunctionFeb 25, 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 21455332 ↗MalfunctionFeb 19, 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. BENDING RUBBER PEELED OFF(BLACK GLUE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21407800 ↗MalfunctionFeb 5, 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 21309901 ↗MalfunctionFeb 5, 2025Optical 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 21309899 ↗MalfunctionJan 7, 2025Obstruction 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 21088538 ↗MalfunctionJan 7, 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 21088433 ↗MalfunctionNov 22, 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 20755567 ↗MalfunctionNov 20, 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 20731325 ↗MalfunctionNov 20, 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 20731217 ↗MalfunctionNov 18, 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 20703174 ↗MalfunctionNov 18, 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 20703158 ↗MalfunctionOct 31, 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 20575888 ↗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 20530442 ↗MalfunctionOct 10, 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 20414410 ↗MalfunctionOct 10, 2024Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(OBJECTIVE LENS BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20414379 ↗MalfunctionSep 19, 2024No 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 20254408 ↗MalfunctionSep 10, 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 20178245 ↗MalfunctionSep 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 20178183 ↗MalfunctionSep 9, 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 20167200 ↗MalfunctionAug 20, 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 20008469 ↗MalfunctionJun 8, 2023Erratic 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 17084529 ↗MalfunctionJun 7, 2023Detachment 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 17076734 ↗MalfunctionJun 7, 2023Obstruction 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 17076478 ↗MalfunctionJun 1, 2023Erratic 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 17036594 ↗
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-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-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-1267-2020 · Jan 3, 2020 · TerminatedPentax Video Colonoscope Model: EC34-i10L
- Z-1268-2020 · Jan 3, 2020 · TerminatedPentax Video Colonoscope Model: EC38-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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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