VIDEO DUODENOSCOPE ED34-I10TRecalls & reported problems
Pentax Of America, Inc. · VIDEO DUODENOSCOPE - I10 STANDARD (INTERNATIONAL USED) · Class 2
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 04961333240128), received between Apr 20, 2021 and Apr 20, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Disconnect” (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.
Most reported problems
Device problems
- Failure to Disconnect1
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.
MalfunctionApr 20, 2021Failure to Disconnect; Failure to Disconnect
PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 22-FEB-2021 OF A "BRUSH STUCK/BROKEN IN CHANNEL" THAT WAS FOUND DURING PRE-INSPECTION CHECK AFTER REPROCESSING, INVOLVING THE PENTAX MEDICAL VIDEO DUODENOSCOPE, MODEL ED34-I10T, SERIAL NUMBER (B)(4). NO SERIOUS INJURY OR DEATH OF A PATIENT OR USER, OR DELAY IN A PROCEDURE WHICH WOULD REQUIRE MEDICAL INTERVENTION WAS REPORTED. THE USER ALSO REPORTED THAT A COOK MEDICAL COTTON-LEUNG BILLIARY STENT, 10CM X 10FR, UNKNOWN CATALOG AND LOT NUMBER WAS USED IN THE PRIOR PROCEDURE. THE CUSTOMER OWNED ENDOSCOPE WAS RETURNED FOR EVALUATION ON 04-JAN-2021. DURING EVALUATION OF THE ENDOSCOPE UNDER SERVICE ORDER (B)(4) AND THE TECHNICIAN DOCUMENTED AN ACCESSORY STUCK IN PRIMARY OPERATION CHANNEL WHICH IS CONSISTENT WITH THE REPORTED ACCESSORY USED IN THE PRIOR PROCEDURE BY THE USER, AS WELL DOCUMENTING THE FOLLOWING INSPECTION FINDINGS ON 10-MAR-2021: INSERTION TUBE BUMP AT STAGE 1, LIGHT CARRYING BUNDLE BUNDLE HAS LESS THAN 70% TRANSMISSION, FAILED WET LEAK TEST, SEGMENT STEEL BRAID CUT, FAILED DRY LEAK TEST, IMAGE DARK, LIGHT CARRYING BUNDLE DISTAL COVER GLASS SINGLE CHIPPED, LEAK AT # 1 REMOTE CONTROL BUTTON COVER, DEFLECTOR LINK PIVOT O-RING REP
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11696112 ↗
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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