PENTAX Medical ED34-i10T2Recalls & reported problems
Hoya Corporation · PENTAX Medical Video Duodenoscope ED34-i10T2 · Class 2
All models of PENTAX Medical (34)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This PENTAX Medical duodenoscope is a flexible scope used to look at the upper intestine. Its 822 reports include 33 injuries and no deaths. Many describe parts breaking, fluid leaks, and blocked lenses or channels, and some describe video image failures. 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
- 826
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 826 adverse event reports that list this exact device (DI 04961333247455), received between Jul 6, 2021 and Sep 25, 2026 — classified as 32 injuries, 794 malfunctions.
The most frequently reported specific device problem is “Break” (390 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
- Break390
- Fluid/Blood Leak106
- Optical Obstruction106
- Obstruction of Flow67
- Detachment of Device or Device Component57
- No Display/Image27
- Erratic or Intermittent Display26
- Optical Distortion15
Patient problems
- No Clinical Signs, Symptoms or Conditions795
- Device Embedded In Tissue or Plaque24
- Foreign Body In Patient8
- Airway Obstruction3
- Cough2
- Perforation2
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 826 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Detachment of Device or Device Component
The time of event is unknown.There was no report of patient harm.Distal body peeled off (Black glue).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893620 ↗MalfunctionSep 25, 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 50893618 ↗MalfunctionSep 17, 2026Detachment of Device or Device Component
The time of event is unknown. There was no report of patient harm. Distal body peeled off (Black glue).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50797939 ↗MalfunctionSep 11, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50726264 ↗MalfunctionSep 8, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50661476 ↗MalfunctionAug 18, 2026Optical Obstruction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50292704 ↗MalfunctionAug 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 50269346 ↗MalfunctionAug 17, 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 50269340 ↗MalfunctionAug 17, 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 50269330 ↗MalfunctionAug 13, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50232164 ↗MalfunctionAug 4, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50125150 ↗MalfunctionAug 4, 2026Optical Obstruction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50125144 ↗MalfunctionJul 28, 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 50049575 ↗MalfunctionJul 21, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25884939 ↗MalfunctionJul 15, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25822211 ↗MalfunctionJun 15, 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 25498301 ↗MalfunctionJun 4, 2026Break
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 25387736 ↗MalfunctionMay 20, 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 25225929 ↗MalfunctionMay 19, 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 25212152 ↗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 25167904 ↗MalfunctionMay 8, 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 25120217 ↗InjuryApr 6, 2026Device Dislodged or Dislocated
ON 12-MAR-2026, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL VIDEO DUODENOSCOPE MODEL: ED34-I10T2 SERIAL NUMBER: (B)(6) IN SPAIN WITHIN THE EMEA REGION. DURING AN ERCP PROCEDURE, THE SINGLE-USE STERILE DISTAL END CAP DETACHED FROM THE ENDOSCOPE DURING WITHDRAWAL OF THE ENDOSCOPE. 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: Airway Obstruction; Foreign Body In Patient
MAUDE report 24795920 ↗InjuryMar 25, 2026Device Dislodged or Dislocated
ON 04-MAR-2026, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL VIDEO DUODENOSCOPE MODEL: ED34-I10T2, SERIAL NUMBER: (B)(6) IN (B)(6), UNITED STATES. DURING AN ENDOSCOPIC PROCEDURE, THE SINGLE-USE STERILE DISTAL END CAP OF THE DUODENOSCOPE BECAME DETACHED INSIDE THE PATIENT'S TRACHEA. THE DISTAL END CAP HAD BEEN ATTACHED PRIOR TO THE PROCEDURE AND ATTACHMENT WAS CONFIRMED WITH AN AUDIBLE CLICK. IT WAS REPORTED THAT THE ENDOSCOPE WAS INSERTED INTO THE TRACHEA INSTEAD OF THE ESOPHAGUS WHILE THE PATIENT WAS NOT IN A FULLY PRONE POSITION. THE PATIENT HAD AN ENDOTRACHEAL TUBE IN PLACE AND THE DISTAL END CAP BECAME LODGED BETWEEN THE TRACHEAL CARTILAGE RINGS. THE DISTAL END CAP SEPARATED INTO TWO PIECES, THE CAP AND THE FORCEPS ELEVATOR, AND WAS DAMAGED. THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S ENDOSCOPE. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED PAIN AND SWELLING AND REQUIRED ADDITIONAL CARE IN THE ICU. 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: Foreign Body In Patient
MAUDE report 24684068 ↗InjuryMar 24, 2026Device Dislodged or Dislocated
MalfunctionMar 19, 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 24636021 ↗
Other duodenoscope and accessories, flexible/rigid devices
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190VOlympus Medical Systems Corp. · Duodenoscope and accessories, flexible/rigid4 recalls10 deaths4,900 reports
- EXALT™ Model D M00542420Boston Scientific Corporation · Duodenoscope and accessories, flexible/rigid4 recalls1 death252 reports
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190VOlympus Medical Systems Corp. · Duodenoscope And Accessories, Flexible/Rigid1 recall381 reports
- EXALT™ Model D M0054242CE0Boston Scientific Corporation · Duodenoscope and accessories, flexible/rigid4 recalls1 death38 reports
- CRE Wireguided M00558470Boston Scientific Corporation · duodenoscope and accessories, flexible/rigid1 recall17 reports
- CRE Wireguided M00558460Boston Scientific Corporation · duodenoscope and accessories, flexible/rigid1 recall11 reports
- FUJIFILM ED-580XTFujifilm Corporation · Duodenoscope And Accessories, Flexible/Rigid60 reports
- PENTAX ED-3490TKHoya Corporation · duodenoscope and accessories, flexible/rigid43 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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