CONNECTING TUBE MAJ-2118Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04953170404139), received between Jul 7, 2022 and Apr 3, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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-1906-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2024Component Missing; Component Missing

  IT WAS REPORTED, THAT THE ENDOSCOPE CONNECTOR WAS MISSING A RETAINING CLIP ON ONE SIDE AND HAVING CONNECTION ISSUES WITH THE MAIN IMAGER. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19037507 ↗
• MalfunctionApr 3, 2024Component Missing; Component Missing

  IT WAS REPORTED, THAT THE ENDOSCOPE CONNECTOR WAS MISSING A RETAINING CLIP ON ONE SIDE AND HAVING CONNECTION ISSUES WITH THE MAIN IMAGER. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19037481 ↗
• MalfunctionApr 3, 2024Component Missing; Component Missing

  IT WAS REPORTED, THAT THE ENDOSCOPE CONNECTOR WAS MISSING A RETAINING CLIP ON ONE SIDE AND HAVING CONNECTION ISSUES WITH THE MAIN IMAGER. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19037464 ↗
• 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 6 OF 14. PLEASE SEE THE FOLLOWING PATIENT IDENTIFIERS FOR THE RELATED EVENTS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18029662 ↗
• MalfunctionJun 7, 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-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-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 17082929 ↗
• MalfunctionJun 2, 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): THIS REPORT (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-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) (MOD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17049429 ↗
• MalfunctionJun 1, 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 17043522 ↗
• MalfunctionMay 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, THE CONNECTING TUBE CANNOT BE CONNECTED TO THE CHANNEL CONNECTOR IN THE REPROCESSING BASIN. THE CUSTOMER STATED THE CONNECTORS ARE FALLING APART. 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).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17013694 ↗
• MalfunctionApr 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, THE CONNECTING TUBE WAS FALLING OFF APART ON THE OER-ELITE REPROCESSOR. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS RELATED TO PATIENT IDENTIFIER (B)(6) (MAJ-2118, 2 OF 2).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16795483 ↗
• MalfunctionJul 7, 2022Disconnection; Disconnection

  THE OLYMPUS SALES REPRESENTATIVE, REPORTED ON BEHALF OF THE CUSTOMER, THE CUSTOMER WAS HAVING A HOSE CONNECTION FAILURE ON THE ENDOSCOPE REPROCESSOR FOR THE FOLLOWING CONNECTION TUBES: MAJ-2110, MAJ-2111, MAJ-2112,MAJ-2330,MAJ2114,MAJ-2115, MAJ-2117 AND MAJ-2118. THE CONNECTORS KEEP COMING OFF. THE CONNECTING TUBES ARE REPORTEDLY BEING RETURNED TO OLYMPUS FOR EVALUATION. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14952373 ↗

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