PENTAX Medical EC34-i20cLRecalls & reported problems
Hoya Corporation · PENTAX Medical Video Colonoscope EC34-i20cL · Class 2
All models of PENTAX Medical (34)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This PENTAX Medical video colonoscope is a flexible camera scope used to look inside the colon. The 58 reports mostly describe the picture going black or freezing up, the lens view being blocked or cloudy, and fluid or blood leaking inside the scope. No deaths and no injuries were reported. There are no recalls for this device. Reports rose sharply, from 13 in the earlier 12 months to 44 in the most recent 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
- 51
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 04961333254668), received between Oct 31, 2024 and Sep 30, 2026 — classified as 51 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (13 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
- Fluid/Blood Leak13
- No Display/Image8
- Optical Obstruction8
- Erratic or Intermittent Display4
- Obstruction of Flow4
- Poor Quality Image4
- Overheating of Device3
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions51
Recent adverse event reports
The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 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 50942350 ↗MalfunctionSep 29, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927540 ↗MalfunctionSep 25, 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 50893624 ↗MalfunctionJul 22, 2026Material Protrusion/Extrusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25903785 ↗MalfunctionJul 15, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25822218 ↗MalfunctionJul 15, 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 25822213 ↗MalfunctionMay 29, 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 25326970 ↗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 25326955 ↗MalfunctionMay 28, 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 25312364 ↗MalfunctionMay 22, 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 25251220 ↗MalfunctionMay 22, 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 25251193 ↗MalfunctionMay 21, 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 25237986 ↗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 25225901 ↗MalfunctionMay 19, 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 25212163 ↗MalfunctionMay 14, 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 25167860 ↗MalfunctionMay 8, 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 25120232 ↗MalfunctionMay 1, 2026Poor Quality Image
ON 10-APR-2026, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL VIDEO COLONOSCOPE MODEL EC34-I20CL, SERIAL NUMBER (B)(6) IN IRELAND WITHIN THE EMEA REGION. DURING A COLONOSCOPIC PROCEDURE, WHEN THE ENDOSCOPE REACHED THE CAECUM, THE ENDOSCOPIC IMAGE BECAME GRAINY AND REDDISH. WHEN THE ENDOSCOPE WAS WITHDRAWN FROM THE PATIENT, THE DISTAL END OF THE ENDOSCOPE WAS FOUND TO BE HOT, AND WASTE MATTER HAD ADHERED AND COAGULATED ON THE ILLUMINATION LENS AT THE DISTAL END. THE PHYSICIAN PERFORMED A BIOPSY ON AN AREA CONSIDERED TO BE A SUSPICIOUS LESION DUE TO THE DETERIORATION IN IMAGE QUALITY, HOWEVER THE AREA WAS IDENTIFIED AS FECAL MATTER. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT ENDOSCOPE, BUT THE PROCEDURE TIME WAS EXTENDED. THE PHYSICIAN REPORTED THAT THE DETERIORATION OF THE ENDOSCOPIC IMAGE INTERFERED WITH THE PROCEDURE AND THAT THE ENDOSCOPE WAS NOT USED FOR THE REMAINING PROCEDURES ON THAT DAY. 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 E
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25055057 ↗MalfunctionApr 27, 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 24994166 ↗MalfunctionMar 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 24592659 ↗MalfunctionMar 11, 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 24565967 ↗MalfunctionMar 4, 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 24504095 ↗MalfunctionFeb 24, 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 24424902 ↗MalfunctionFeb 24, 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 24424891 ↗MalfunctionFeb 16, 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 24341823 ↗MalfunctionFeb 9, 2026Overheating of Device
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. LCB DISTAL COVER GLASS DIRTY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24288768 ↗
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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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