CONNECTING TUBE MAJ-2358Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of CONNECTING TUBE (23)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170409820), received between Sep 12, 2023 and Sep 12, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Reprocessing Problem” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K202661); 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Reprocessing Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 12, 2025Device Reprocessing Problem; Device Reprocessing Problem
NO ADDITIONAL CUSTOMER INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23041812 ↗MalfunctionSep 12, 2023Device Reprocessing Problem; Device Reprocessing Problem
AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER, WHEN THE EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE (GF-UCT260) WAS REPROCESSED IN ENDOSCOPE REPROCESSOR (OER-4), THERE WAS A POSSIBILITY THAT THE COMBINATION OF WASHING TUBES (MAJ-1517 AND MAJ-2358) WERE USED INSTEAD OF THE ORIGINAL COMBINATION OF CONNECTING TUBES (MAJ-1971 AND MAJ-1517). THE EVENT OCCURRED DURING REPROCESSING. THE ISSUE WAS DISCOVERED WHEN A NURSE ASKED ABOUT THE COMBINATION OF IRRIGATION TUBES. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIERS: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17733322 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K202661. One submission often covers many models, so check the product and lot details in each record.
- Z-2467-2023 · Jul 27, 2023 · Open, ClassifiedEVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
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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