CONNECTING TUBE MAJ-2113Recalls & 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 links an endoscope to its reprocessing equipment during cleaning. Reports mostly describe the tube breaking or coming apart during reprocessing, often at its lock levers. The 159 reports include no deaths and no injuries. One open recall, begun in March 2026, concerns the lock levers on this reprocessor connecting tube, which may break early.
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
- 159
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 159 adverse event reports that list this exact device (DI 04953170404085), received between Mar 15, 2022 and Oct 17, 2025 — classified as 159 malfunctions.
The most frequently reported specific device problem is “Break” (78 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-1901-2026 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Break78
- Connection Problem44
- Detachment of Device or Device Component18
- Incomplete or Inadequate Connection9
- Fracture6
- Disconnection4
- Component Missing3
- Crack3
Patient problems
- No Clinical Signs, Symptoms or Conditions159
Recent adverse event reports
The 25 most recent of 159 reports, in the reporter's own words as published by the FDA.
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 23327817 ↗MalfunctionOct 17, 2025Degraded; Degraded
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23327714 ↗MalfunctionFeb 21, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21437173 ↗MalfunctionJan 10, 2025Break; Disconnection; Break; Disconnection
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21129979 ↗MalfunctionJan 10, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21123566 ↗MalfunctionJan 10, 2025Disconnection; Disconnection
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21123327 ↗MalfunctionOct 28, 2024Break; Break
IT WAS REPORTED THE CONNECTING TUBE HAD BROKEN LOCK LEVERS. IT WAS NOT REPORTED DURING WHAT TYPE OF DEVICE USAGE THE REPORTED EVENT OCCURRED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20553527 ↗MalfunctionOct 23, 2024Connection Problem; Connection Problem
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 20517935 ↗MalfunctionOct 23, 2024Connection Problem; Connection Problem
IT WAS REPORTED THAT THE CONNECTING TUBE CHANNEL CONNECTOR WAS BROKEN. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20517599 ↗MalfunctionOct 23, 2024Connection Problem; Connection Problem
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 20516442 ↗MalfunctionOct 23, 2024Connection Problem; Connection Problem
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 20516006 ↗MalfunctionOct 23, 2024Connection Problem; Connection Problem
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 20515955 ↗MalfunctionOct 23, 2024Break; Break
IT WAS REPORTED THAT THE SUCTION CONNECTOR AND THE AUXILIARY WATER CONNECTOR WERE BROKEN FOR NO REASON. CONSEQUENTLY, THERE WAS CANCELLATION OF ALL PROCEDURES ON BECAUSE THE FACILITY COULD NOT REPROCESS THE SCOPES. THE ISSUE OCCURRED DURING REPROCESSING WITH NO EVIDENCE OF DIRECT PATIENT INVOLVEMENT. THOUGH PROCEDURES WERE CANCELLED, THERE WAS NO INDICATION THAT THESE WERE BEING DONE URGENTLY OR EMERGENTLY FOR LIFE-THREATENING REASONS OR THAT THE CANCELLATION OF SAID PROCEDURES CAUSED ANY LIFE-THREATENING COMPLICATIONS OR HEALTH CONDITIONS. AT THIS TIME, THERE IS NO EVIDENCE THAT A LIFE-THREATENING EVENT OCCURRED, THAT A PATIENT HAS DEVELOPED A PERMANENT DISABILITY OR PERMANENT DAMAGE THAT CAUSED SUBSTANTIAL DISRUPTION IN THEIR ABILITY TO CONDUCT NORMAL LIFE FUNCTIONS, OR THAT ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR DAMAGE TO A BODY STRUCTURE THAT IS SUSPECTED TO BE DUE TO THE USE OF THE OLYMPUS DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20513413 ↗MalfunctionOct 22, 2024Break; Break
IT WAS REPORTED THE REPROCESSOR CONNECTING TUBE CLIPS WERE BREAKING OFF OFTEN. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20507463 ↗MalfunctionOct 14, 2024Degraded; Degraded
IT WAS REPORTED CONNECTING TUBE WAS FADING AND SHOWING WEAKENING OF THE PLASTIC AND SUPER SMALL CRACKS ALONG THE CONNECTORS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20436728 ↗MalfunctionOct 9, 2024Break; Break
IT WAS REPORTED THE CONNECTING TUBES FROM THE ENDOSCOPES TO THE REPROCESSOR WERE FRAGILE AND BREAKING OFTEN. THE COLORED ENDS HAVE TWO PLASTIC CLIPS WHICH HOLD THE CONNECTING TUBES TO THE REPROCESSOR, THESE CLIPS WERE BREAKING OFF. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20413795 ↗MalfunctionSep 27, 2024Break; Break
IT WAS REPORTED THAT THE CONNECTING TUBE HAD BROKEN CONNECTORS. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20322512 ↗MalfunctionSep 25, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED, THE ENDOSCOPE REPROCESSOR ACCESSORIES CONNECTING TUBE ON THE REPROCESSER ARE BREAKING AND POPPING OFF MID CYCLE. THE ISSUE OCCURRED DURING [EVENT]. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20302818 ↗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 20302745 ↗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 20302163 ↗MalfunctionSep 23, 2024Break; Break
IT WAS REPORTED THAT THE CONNECTING TUBE HAD BROKEN CONNECTORS. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20280510 ↗MalfunctionSep 20, 2024Break; Break
IT WAS REPORTED THAT THE CONNECTING TUBE HAD BROKEN CONNECTORS. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20268943 ↗MalfunctionSep 17, 2024Break; Break
IT WAS REPORTED, THE CONNECTING TUBE'S CONNECTORS ON BOTH OER-ELITES WERE BREAKING AND POPPING OFF MID CYCLE ON BOTH OER-ELITES. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20242648 ↗MalfunctionSep 16, 2024Break; Break
IT WAS REPORTED THAT THE CONNECTING TUBE HAD BROKEN CONNECTORS. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20232398 ↗MalfunctionSep 4, 2024Break; Break
IN SPEAKING WITH THE OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), THE CUSTOMER REPORTED THAT THE TAB BROKE ON MAJ-2113, THE CUSTOMER WAS THEN LATER TRANSFERRED TO CUSTOMER CARE TO OBTAIN AN RMA. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20140464 ↗
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-2111Olympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope1 recall164 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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