CONNECTING TUBE MAJ-2114Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04953170404092), received between Nov 19, 2022 and Jul 3, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (6 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.

Recalls naming this device

1. Mar 25, 2026Class IIOpen, Classified

   Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

   Z-1902-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2024Break; Break

  IT WAS REPORTED, THE CONNECTING TUBE WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19670854 ↗
• MalfunctionApr 10, 2024Break; Break

  AN OLYMPUS REPRESENTATIVE REPORTED THAT THE OER-ELITE (ENDOSCOPE REPROCESSOR) SEPARATED HOOK PART CONNECTOR TUBE CONTINUED TO BREAK OFF. THE REPORTED ISSUE WAS OBSERVED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19078472 ↗
• MalfunctionFeb 12, 2024Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THE TAB BROKE ON THE CONNECTING TUBE MAKING IT IMPOSSIBLE TO CONNECT TO THE ENDOSCOPE REPROCESSOR. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18692525 ↗
• MalfunctionFeb 12, 2024Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THE TAB BROKE ON THE REPROCESSOR CONNECTING TUBE MAKING IT IMPOSSIBLE TO CONNECT TO THE ENDOSCOPE. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18692515 ↗
• MalfunctionOct 30, 2023Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT WHILE REPROCESSING VARIOUS OLYMPUS CONNECTING TUBES, THE CLIPS BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT DURING THESE EVENTS. THIS REPORT IS 8 OF 14. PLEASE SEE THE FOLLOWING PATIENT IDENTIFIERS FOR THE RELATED EVENTS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18030000 ↗
• MalfunctionOct 30, 2023Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT WHILE REPROCESSING VARIOUS OLYMPUS CONNECTING TUBES, THE CLIPS BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT DURING THESE EVENTS. THIS REPORT IS 8 OF 14. PLEASE SEE THE FOLLOWING PATIENT IDENTIFIERS FOR THE RELATED EVENTS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18029996 ↗
• MalfunctionSep 28, 2023Break; Break

  THE OLYMPUS REPRESENTATIVE REPORTED (ON BEHALF OF THE CUSTOMER) THAT THE CONNECTING TUBE WING BROKE AFTER A FEW USES. THE ISSUE WAS FOUND IN THE IN CLEANING AND DISINFECTION ROOM. THERE WAS NO PATIENT INVOLVEMENT AND NO USER INJURY. RELATED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17833293 ↗
• MalfunctionSep 28, 2023Break; Break

  THE OLYMPUS REPRESENTATIVE REPORTED (ON BEHALF OF THE CUSTOMER) THAT THE CONNECTING TUBE WING BROKE AFTER A FEW USES. THE ISSUE WAS FOUND IN THE IN CLEANING AND DISINFECTION ROOM. THERE WAS NO PATIENT INVOLVEMENT AND NO USER INJURY. RELATED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17833129 ↗
• MalfunctionJun 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE CONNECTING TUBE CANNOT BE CONNECTED TO THE CHANNEL CONNECTOR IN THE REPROCESSING BASIN. THE CUSTOMER STATED THE CONNECTORS ARE FALLING APART. THE CONNECTORS BECAME DETACHED TOO EASILY AND AT TIMES, THE CONNECTOR HOOK BECOMES DETACHED FROM THE CONNECTOR. THERE WAS A METAL CLIP IN THE CLASPS THAT FALLS OFF, CAUSING THE PLASTIC ¿WINGS¿ TO COME OFF THE CONNECTOR. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE MEDICAL DEVICE REPORT (MDR) IS RELATED TO THE FOLLOWING PATIENT IDENTIFIERS: (B)(6) (MODEL NUMBER: MAJ-2330). (B)(6) (MODEL NUMBER: MAJ-2330). (B)(6) (MODEL NUMBER: MAJ-2330). (B)(6) (MODEL NUMBER: MAJ-2330). (B)(6) (MODEL NUMBER: MAJ-2118). (B)(6) (MODEL NUMBER: MAJ-2118). (B)(6) (MODEL NUMBER: MAJ-2118). (B)(6) (MODEL NUMBER: MAJ-2118). (B)(6) (MODEL NUMBER: MAJ-2115). (B)(6) (MODEL NUMBER: MAJ-2115). (B)(6) (MODEL NUMBER: MAJ-2115). (B)(6) (MODEL NUMBER: MAJ-2115). (B)(6) (MODEL NUMBER: MAJ-2114). (B)(6) (MODEL NUMBER: MAJ-2114). (B)(6) (MODEL NUMBER: MAJ-2114). (B)(6) (MODEL NUMBER: MAJ-2116). (B)(6) (MODEL NUMBER: MAJ-2116). (B)(6) (MODEL NUMBER: MAJ-2116). (B)(6) (MODEL NUMBER: MAJ-2116). (B)(6) (MODEL NUMBER: MAJ-2138). (B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17086988 ↗
• MalfunctionJun 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE CONNECTING TUBE CANNOT BE CONNECTED TO THE CHANNEL CONNECTOR IN THE REPROCESSING BASIN. THE CUSTOMER STATED THE CONNECTORS ARE FALLING APART. THE CONNECTORS BECAME DETACHED TOO EASILY AND AT TIMES, THE CONNECTOR HOOK BECOMES DETACHED FROM THE CONNECTOR. THERE WAS A METAL CLIP IN THE CLASPS THAT FALLS OFF, CAUSING THE PLASTIC ¿WINGS¿ TO COME OFF THE CONNECTOR. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE MEDICAL DEVICE REPORT (MDR) IS RELATED TO THE FOLLOWING PATIENT IDENTIFIERS: (B)(6) (MODEL NUMBER: MAJ-2330); (B)(6) (MODEL NUMBER: MAJ-2330); (B)(6) (MODEL NUMBER: MAJ-2330); (B)(6) (MODEL NUMBER: MAJ-2330); (B)(6) (MODEL NUMBER: MAJ-2118); (B)(6) (MODEL NUMBER: MAJ-2118); (B)(6) (MODEL NUMBER: MAJ-2118); (B)(6) (MODEL NUMBER: MAJ-2118); (B)(6) (MODEL NUMBER: MAJ-2115); (B)(6) (MODEL NUMBER: MAJ-2115); (B)(6) (MODEL NUMBER: MAJ-2115); (B)(6) (MODEL NUMBER: MAJ-2114); (B)(6) (MODEL NUMBER: MAJ-2114); (B)(6) (MODEL NUMBER: MAJ-2114): THIS REPORT (B)(6) (MODEL NUMBER: MAJ-2114); (B)(6) (MODEL NUMBER: MAJ-2116); (B)(6) (MODEL NUMBER: MAJ-2116); (B)(6) (MODEL NUMBER: MAJ-2116); (B)(6) (MODEL NUMBER: MAJ-2138); (B)(6) (MODEL NUMBER: M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17086920 ↗
• MalfunctionJun 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE CONNECTING TUBE CANNOT BE CONNECTED TO THE CHANNEL CONNECTOR IN THE REPROCESSING BASIN. THE CUSTOMER STATED THE CONNECTORS ARE FALLING APART. THE CONNECTORS BECAME DETACHED TOO EASILY AND AT TIMES, THE CONNECTOR HOOK BECOMES DETACHED FROM THE CONNECTOR. THERE WAS A METAL CLIP IN THE CLASPS THAT FALLS OFF, CAUSING THE PLASTIC ¿WINGS¿ TO COME OFF THE CONNECTOR. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE MEDICAL DEVICE REPORT (MDR) IS RELATED TO THE FOLLOWING PATIENT IDENTIFIERS: (B)(6) (MODEL NUMBER: MAJ-2330), (B)(6) (MODEL NUMBER: MAJ-2118), (B)(6) (MODEL NUMBER: MAJ-2115), (B)(6) (MODEL NUMBER: MAJ-2114), (B)(6) (MODEL NUMBER: MAJ-2116), (B)(6) (MODEL NUMBER: MAJ-2138).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17086612 ↗
• MalfunctionMay 31, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE CONNECTING TUBE CANNOT BE CONNECTED TO THE CHANNEL CONNECTOR IN THE REPROCESSING BIN. THERE IS A METAL CLIP IN THE CLASPS THAT FALLS OFF, CAUSING THE PLASTIC ¿WINGS¿ TO COME OFF THE CONNECTOR. THE REPORTED PROBLEM WAS FOUND DURING USE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17033411 ↗
• MalfunctionNov 19, 2022Separation Problem; Separation Problem

  THE CUSTOMER REPORTED TO OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), THERE WERE MULTIPLES OER-ELITE CONNECTORS THAT WERE ¿BAD¿. THE CUSTOMER REPORTED THAT IT WAS AN OUT OF BOX FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15831066 ↗

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 · Terminated
  OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessor