PENTAX Medical ED34-i10T2sRecalls & reported problems
Hoya Corporation · PENTAX Medical Video Duodenoscope ED34-i10T2s · Class 2
All models of PENTAX Medical (34)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04961333356355), received between Feb 13, 2025 and Feb 13, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “No Display/Image” (1 report).
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
- No Display/Image1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 13, 2025No 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 21371180 ↗
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
- PENTAX Medical ED34-i10T2Hoya Corporation · duodenoscope and accessories, flexible/rigid826 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
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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