CONNECTING TUBE MAJ-2138Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04953170404184), received between Mar 15, 2022 and Oct 31, 2023 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (8 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-1908-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2023Break; Break

  THE SALES REPRESENTATIVE REPORTED TO OLYMPUS, THE CONNECTING TUBE CLIPS BROKE OFF OF ALL THE CONNECTORS. THE ISSUE WAS FOUND DURING REPROCESSING. THE WASHER WAS MOVED TO A SISTER FACILITY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18044601 ↗
• MalfunctionOct 31, 2023Break; Break

  THE SALES REPRESENTATIVE REPORTED TO OLYMPUS, THE CONNECTING TUBE CLIPS BROKE OFF OF ALL THE CONNECTORS. THE ISSUE WAS FOUND DURING REPROCESSING. THE WASHER WAS MOVED TO A SISTER FACILITY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18044589 ↗
• 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 14 OF 14. PLEASE SEE THE FOLLOWING PATIENT IDENTIFIERS FOR THE RELATED EVENTS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18030968 ↗
• 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 9 OF 14. PLEASE SEE THE FOLLOWING PATIENT IDENTIFIERS FOR THE RELATED EVENTS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18030174 ↗
• MalfunctionJun 9, 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-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)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097393 ↗
• MalfunctionJun 9, 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-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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097279 ↗
• MalfunctionJun 9, 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-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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097228 ↗
• MalfunctionJun 9, 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-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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097127 ↗
• MalfunctionMar 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING PREPARATION FOR USE THE CUSTOMER OBSERVED THAT THE DEVICE WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. FOLLOW UP WAS PERFORMED AND THE FOLLOWING INFORMATION OBTAINED: THIS PHENOMENON DID NOT CAUSE ANY HEALTH PROBLEMS. THE SUBJECT DEVICE WAS SENT BACK TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING THE FOLLOWING WAS FOUND: CONNECTING TUBE CANNOT BE CONNECTED TO THE CHANNEL CONNECTOR IN THE REPROCESSING BASIN. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (CONNECTING TUBE CANNOT BE CONNECTED TO THE CHANNEL CONNECTOR IN THE REPROCESSING BASIN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16507522 ↗
• MalfunctionFeb 22, 2023Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THE CONNECTOR ON THE SUBJECT DEVICE WAS BROKEN DURING INSTALLATION OF THE ENDOSCOPE REPROCESSOR. THERE WAS NO PROCEDURAL IMPACT OR PATIENT HARM ASSOCIATED WITH THE EVENT. THE SUBJECT DEVICE WAS SENT TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING, THE DEVICE COULD NOT BE CONNECTED TO THE REPROCESSOR. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (UNABLE TO CONNECT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16417458 ↗
• MalfunctionFeb 22, 2023Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THE SUBJECT DEVICE BROKE AND COULD NOT BE CONNECTED IN THE REPROCESSING BASIN. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16416696 ↗
• MalfunctionFeb 15, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), THE CONNECTING TUBE WAS CRACKED/BROKEN AND COULD NOT BE CONNECTED. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. THIS REPORT IS PART OF A RELATED EVENT. (PATIENT IDENTIFIER : (B)(6)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16378699 ↗
• MalfunctionFeb 15, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), THE CONNECTING TUBE WAS CRACKED/BROKEN AND COULD NOT BE CONNECTED. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. THIS REPORT IS PART OF A RELATED EVENT. (PATIENT IDENTIFIER: (B)(6))

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16378541 ↗
• MalfunctionJan 9, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE TABS ON THE CONNECTING TUBE HAD BROKEN OFF. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16122320 ↗
• MalfunctionDec 21, 2022Break; Connection Problem; Break; Connection Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING INITIAL USE THE CONNECTING TUBE WAS BROKEN AND CANNOT BE CONNECTED TO THE CHANNEL CONNECTOR IN THE REPROCESSING BASIN. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16022002 ↗
• MalfunctionOct 10, 2022Break; Break

  AS REPORTED BY THE CUSTOMER TO THE OLYMPUS SPECIALIST, THE CUSTOMER REPLACEMENT DEVICE SNAPPED AND BROKE AND A NEW ONE NEEDED TO BE ORDERED. THERE IS NO PATIENT INVOLVEMENT AND NO HARM REPORTED TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15573523 ↗
• MalfunctionMar 15, 2022Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THE FSE (FIELD SERVICE ENGINEER) ONSITE FOUND THE CLIP INSIDE THE CONNECTOR WAS MISSING AND CANNOT BE ATTACHED TO THE REPROCESSOR. FOUR (4) CONNECTORS WERE IDENTIFIED WITH THE SAME ISSUE. THE ISSUE FOUND DURING AN UNKNOWN EVENT. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS REPORTED EVENT. NO USER INJURY REPORTED. THIS REPORT IS RELATED TO A REPORT WITH PATIENT IDENTIFIERS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13767501 ↗

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