PENTAX EC-3490TLiRecalls & reported problems
Hoya Corporation · PENTAX VIDEO COLONOSCOPE EC-3490Ti SERIES · Class 2
All models of PENTAX (72)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Pentax EC-3490Ti video colonoscope is a flexible scope used to examine the colon. The 73 adverse event reports mostly describe parts coming apart or breaking, such as the air/water nozzle peeling off the scope, along with cloudy or failed video images and clogged air/water tubes. No deaths and no injuries are reported. No recalls name this device, and the reports have dropped from 5 in the prior 12 months to none in the last 12 months.
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
- 73
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 04961333224982), received between Aug 6, 2021 and Mar 3, 2025 — classified as 73 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (21 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
- Detachment of Device or Device Component21
- Break20
- No Display/Image10
- Obstruction of Flow6
- Optical Obstruction6
- Fluid/Blood Leak5
- Erratic or Intermittent Display3
- Optical Distortion2
Patient problems
- No Clinical Signs, Symptoms or Conditions73
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 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 21501543 ↗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 21501522 ↗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. AIR/WATER NOZZLE PEELED OFF (BLACK GLUE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21407842 ↗MalfunctionJan 10, 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 21121320 ↗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 20703157 ↗MalfunctionOct 31, 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 20575887 ↗MalfunctionJun 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 19495928 ↗MalfunctionApr 17, 2024Break; Break
THE TIME OF EVENT IS NOT DURING PROCEDURE.THERE WAS NO REPORT OF PATIENT HARM.VIDEO IMAGE FAILURE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19122851 ↗MalfunctionApr 9, 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 19068932 ↗MalfunctionMar 12, 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 18883288 ↗MalfunctionMar 7, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
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 18853622 ↗MalfunctionMar 7, 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 18853419 ↗MalfunctionFeb 28, 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 18794786 ↗MalfunctionFeb 28, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18794759 ↗MalfunctionFeb 15, 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 18708596 ↗MalfunctionFeb 6, 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 18648002 ↗MalfunctionJan 25, 2024No Display/Image; No Display/Image
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(BLACKOUT ).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18577297 ↗MalfunctionDec 13, 2023No Display/Image; No Display/Image
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(BLACKOUT ).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18316079 ↗MalfunctionNov 27, 2023Poor Quality Image; Failure to Clean Adequately; Poor Quality Image; Failure to Clean Adequately
THE ENDOSCOPE HAD A SMUDGED AND BLOCKED VISION ON LENS-STREAM OF WATER THAT IS SUPPOSE TO COME OUT OF WATER FEEDING CHANNEL WAS WEAK/NOT ABLE TO CLEAR DEBRIS; ANY VISUAL DISTURBANCE HAS POTENTIAL FOR MISSING PATHOLOGY." "LOANER SCOPE PILOT COLONOSCOPE- SMUDGE TO LEFT SIDE OF LENS DURING COLONOSCOPY; POTENTIAL FOR MISSED PATHOLOGY" "BLURRY IMAGE ALL OVER LENS FROM SCOPE PILOT COLONOSCOPE; POTENTIAL TO MISS PATHOLOGY WHEN THIS HAPPENS" "SMUDGE TO LENS- A LINE FROM 2-7 O CLOCK; POTENTIAL FOR MISSED PATHOLOGY" "BLURRINESS TO RIGHT LOWER QUADRANT ON LENS; POTENTIAL FOR MISSED PATHOLOGY" "BLURRINESS TO LENS DURING COLONOSCOPY; FROM 7-9 O CLOCK POSITION. UNABLE TO ASSESS THE REST OF COLON ACCURATELY; UNABLE TO ASSESS FOR PATHOLOGY/POTENTIAL FOR PERFORATION" "BLURRINESS TO LENS DURING COLONOSCOPY; UNABLE TO ASSESS COLON FOR PATHOLOGY/POTENTIAL FOR PERFORATION OF COLON". THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18213288 ↗MalfunctionNov 22, 2023Break; Break
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(BLACKOUT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18188825 ↗MalfunctionNov 13, 2023No Display/Image; No Display/Image
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(BLACKOUT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18117558 ↗MalfunctionNov 13, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18117553 ↗MalfunctionNov 9, 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 18098269 ↗MalfunctionNov 8, 2023Optical Obstruction; Optical Obstruction
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 18089643 ↗MalfunctionNov 7, 2023No Display/Image; No Display/Image
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(BLACKOUT ).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18081701 ↗
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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