PENTAX Medical EC38-i10cL (UDI 04961333247400)Recalls & reported problems
Hoya Corporation · PENTAX Medical Video Colonoscope EC38-i10c Series · 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 colonoscope, a flexible scope used to look inside the colon. The 1,616 reports often describe blocked or distorted camera images, parts breaking, and display or image failures. Some describe fluid or blood leaking into the scope. The records include no deaths, 42 injuries and 1,574 malfunctions, and 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
- 1,618
- Deaths reported
- 0
- Injuries reported
- 42
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,618 adverse event reports that list this exact device (DI 04961333247400), received between Jul 23, 2021 and Sep 25, 2026 — classified as 42 injuries, 1,576 malfunctions.
The most frequently reported specific device problem is “Optical Obstruction” (580 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 Obstruction580
- Break267
- Erratic or Intermittent Display231
- Fluid/Blood Leak182
- Optical Distortion132
- No Display/Image109
- Obstruction of Flow41
- Microbial Contamination of Device34
Patient problems
- No Clinical Signs, Symptoms or Conditions1,604
- Insufficient Information22
- Pain4
- Bacterial Infection2
Recent adverse event reports
The 25 most recent of 1,618 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 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 50893626 ↗MalfunctionSep 24, 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 50877465 ↗MalfunctionSep 17, 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 50797937 ↗MalfunctionSep 16, 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 50782721 ↗MalfunctionSep 16, 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 50782717 ↗MalfunctionAug 31, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50515239 ↗MalfunctionAug 28, 2026Optical Obstruction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50490854 ↗MalfunctionAug 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 50400865 ↗MalfunctionAug 18, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50292698 ↗MalfunctionAug 18, 2026Optical Obstruction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50292694 ↗MalfunctionAug 13, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50232169 ↗MalfunctionAug 13, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50232153 ↗MalfunctionAug 12, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50217979 ↗MalfunctionAug 10, 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 50189586 ↗MalfunctionAug 10, 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 50189583 ↗MalfunctionAug 5, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50137435 ↗MalfunctionAug 3, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50111529 ↗MalfunctionAug 3, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50111521 ↗MalfunctionAug 3, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50111515 ↗MalfunctionAug 3, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50111510 ↗MalfunctionJul 28, 2026Optical Obstruction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50049580 ↗MalfunctionJul 21, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25884946 ↗MalfunctionJul 21, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25884938 ↗MalfunctionJul 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 25758141 ↗MalfunctionJul 3, 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 25703733 ↗
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
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-HQ190IOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid2 recalls1,315 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.
How reports and recalls are matched · Editorial policy · Report an error on this page