CONNECTING TUBE MAJ-2111Recalls & 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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus connecting tube is an accessory used for endoscope cleaning. All 164 of its adverse event reports are malfunctions, with no injuries and no deaths. Most describe the tube's clips or lock levers breaking, often during cleaning and disinfection, with some describing it coming apart. One open recall, started in March 2026, concerns lock levers on a newer version that may fail early. Reports fell from 5 in the prior 12 months to 0 in the last 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
- 164
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 164 adverse event reports that list this exact device (DI 04953170404061), received between Mar 15, 2022 and Oct 17, 2025 — classified as 164 malfunctions.
The most frequently reported specific device problem is “Break” (92 reports).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K190969); 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
Recalls naming this device
- Mar 25, 2026Class IIOpen, Classified
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Z-1899-2026 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Break92
- Connection Problem32
- Detachment of Device or Device Component18
- Disconnection8
- Fracture4
- Crack3
- Material Integrity Problem3
- Material Separation3
Patient problems
- No Clinical Signs, Symptoms or Conditions164
Recent adverse event reports
The 25 most recent of 164 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 17, 2025Degraded; Degraded
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23327990 ↗MalfunctionOct 17, 2025Degraded; Degraded
IT WAS REPORTED THAT THE CONNECTING TUBE WAS DEFECTIVE AND BECAME DISCONNECTED DURING THE ALCOHOL FLUSH PHASE OF THE REPROCESSING CYCLE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23325993 ↗MalfunctionFeb 25, 2025Break; Break
IT WAS REPORTED THAT THE CONNECTOR TUBE CLIPS WERE BROKEN DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21457438 ↗MalfunctionFeb 24, 2025Break; Break
IT WAS REPORTED THAT THE CONNECTOR TUBE CLIPS WERE BROKEN DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21445622 ↗MalfunctionFeb 3, 2025Break; Break
IT WAS REPORTED THAT THE CONNECTING TUBE HAD A BROKEN PLASTIC CONNECTOR. THE EVENT OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21294094 ↗MalfunctionOct 23, 2024Break; Break
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE CONNECTING TUBE HAD BOTH LOCK LEVERS WERE BROKEN OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20519291 ↗MalfunctionOct 16, 2024Break; Connection Problem; Break; Connection Problem
IT WAS REPORTED THAT THE CONNECTING TUBE (AN ENDOSCOPE REPROCESSOR ACCESSORY) COULD NOT BE CONNECTED TO THE CHANNEL CONNECTOR IN THE REPROCESSING BASIN DUE TO BROKEN CLIPS. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20458853 ↗MalfunctionOct 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
DURING THE DEVICE EVALUATION, THE CONNECTING TUBE EXHIBITED BROKEN LOCK LEVERS ON THE REPROCESSOR SIDE CONNECTOR. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20457295 ↗MalfunctionOct 14, 2024Crack; Material Integrity Problem; Crack; Material Integrity Problem
IT WAS REPORTED THAT THE CONNECTOR OF THE ENDOSCOPE CONNECTING TUBE WAS FADING SHOWING A WEAKING OF THE PLASTIC AND SUPER SMALL CRACK. IT IS UNKNOWN WHEN THE REPORTED ISSUE OCCURRED. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20447889 ↗MalfunctionSep 25, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE CONNECTING TUBE CONNECTORS WERE BREAKING AND POPPING OFF MID CYCLE ON BOTH ENDOSCOPE REPROCESSORS. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20304389 ↗MalfunctionSep 25, 2024Break; Disconnection; Break; Disconnection
IT WAS REPORTED THE CONNECTING TUBE CONNECTORS WERE BREAKING AND POPPING OFF MID CYCLE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20303641 ↗MalfunctionSep 25, 2024Break; Break
THE CUSTOMER CALLED AND REPORTED THAT THE CONNECTORS ON HER OLYMPUS CONNECTING TUBES WERE BREAKING AND POPPING OFF MID-CYCLE DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20302930 ↗MalfunctionSep 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE CONNECTING TUBE CLIPS HAD CRACKED AND BROKEN. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20260328 ↗MalfunctionSep 16, 2024Material Separation; Material Separation
IT WAS REPORTED THAT, THE CLEAR PLASTIC ON CONNECTING TUBE SEPARATED FROM THE METAL PORTION. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20226280 ↗MalfunctionSep 12, 2024Break; Break
IT WAS REPORTED THAT THE CONNECTING TUBE'S CONNECTOR WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20208428 ↗MalfunctionSep 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED, THAT THE CONNECTING TUBE'S TAB BROKE OFF. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20194780 ↗MalfunctionSep 11, 2024Break; Break
IT WAS REPORTED THAT THE CONNECTING TUBE'S CONNECTOR WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20189253 ↗MalfunctionSep 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE CONNECTING TUBE WAS DAMAGED WHEN DISCONNECTING AFTER REPROCESSING. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20172160 ↗MalfunctionSep 9, 2024Connection Problem; Connection Problem
IT WAS REPORTED, THE CONNECTING TUBE EXHIBITED CONNECTING TUBE COULD NOT BE CONNECTED TO THE CHANNEL CONNECTOR IN THE REPROCESSING BASIN. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF DELAY, PATIENT HARM, INJURY, OR DEATH. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20169175 ↗MalfunctionSep 9, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE CONNECTING TUBE BROKE AND CANNOT BE CONNECTED. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20168014 ↗MalfunctionSep 9, 2024Break; Break
IT WAS REPORTED, THE CONNECTING TUBE EXHIBITED THE CONNECTORS ON BOTH OER-ELITES ARE BREAKING AND POPPING OFF MID CYCLE ON BOTH OER-ELITES.. THE ISSUE IS UNKNOWN AS TO WHEN IT OCCURRED. THERE WERE NO REPORTS OF DELAY, PATIENT HARM, INJURY, OR DEATH. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20167752 ↗MalfunctionAug 21, 2024Break; Break
THE REPORTED ISSUE WAS NOTICED AFTER REPROCESSING AND IT WAS CONFIRMED THAT THE DEVICE WAS INSPECTED BEFORE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20014214 ↗MalfunctionAug 18, 2024Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED THAT THE CONNECTING TUBE CANNOT BE CONNECTED TO THE CHANNEL CONNECTOR IN THE REPROCESSING BASIN. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19999096 ↗MalfunctionAug 15, 2024Break; Break
IT WAS REPORTED THAT THE CONNECTING TUBE WAS BROKEN. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19989347 ↗MalfunctionAug 6, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS REPORTED, THE CONNECTING TUBE EXHIBITED CANNOT BE CONNECTED TO THE CHANNEL CONNECTOR DUE TO POOR REPROCESSING. THE ISSUE IS UNKNOWN AS TO WHEN IT OCCURRED. THERE WERE NO REPORTS OF DELAY, PATIENT HARM, INJURY, OR DEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19920489 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K190969. One submission often covers many models, so check the product and lot details in each record.
- Z-0638-2022 · Dec 13, 2021 · TerminatedOER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessor
Other Accessories, Cleaning, For Endoscope devices
- ENDOSCOPE REPROCESSOR OER-ProOlympus Medical Systems Corp. · ACCESSORIES, CLEANING, FOR ENDOSCOPE3 recalls1,163 reports
- ENDOSCOPE REPROCESSOR OER-EliteOlympus Medical Systems Corp. · Accessories, cleaning, for endoscope4 recalls323 reports
- SINGLE USE DISTAL COVER MAJ-2315Olympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope2 recalls294 reports
- CONNECTING TUBE MAJ-2110Olympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope1 recall213 reports
- CONNECTING TUBE MAJ-2113Olympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope1 recall159 reports
- CONNECTING TUBE MAJ-2112Olympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope1 recall143 reports
- ENDOSCOPE REPROCESSOR OER-MINIOlympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope2 recalls11 reports
- Medivators HookupMedivators Inc. · Accessories, cleaning, for endoscope2 recalls0 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 · each recall links to the FDA recall notice
- 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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