CONNECTING TUBE MAJ-2330Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04953170404207), received between Nov 19, 2022 and May 20, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (7 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-1909-2026 · 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.

• MalfunctionMay 20, 2026Device Reprocessing Problem; Use of Device Problem; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION AT THE CUSTOMER SITE, THAT THE CONNECTING TUBE EXHIBITED VISIBLE DEBRIS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25232904 ↗
• MalfunctionFeb 27, 2026Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ENDOSCOPE REPROCESSOR HAD A BROKEN CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471621 ↗
• MalfunctionNov 15, 2024Break; Break

  IT WAS REPORTED THAT THE CONNECTING TUBE HAD A BROKEN CONNECTOR FOR THE ENDOSCOPE REPROCESSOR. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20692374 ↗
• MalfunctionNov 5, 2024Break; Break

  IT WAS REPORTED THE CONNECTING TUBE TUBING CLIPS BROKE OFF. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20615307 ↗
• MalfunctionJul 12, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19735556 ↗
• MalfunctionJun 26, 2024Break; Break

  IT WAS REPORTED THE CONNECTING TUBE WAS FRAGILE AND BREAKING, THUS NEEDING TO BE REPLACED FREQUENTLY. THE ISSUE OCCURRED DURING PREPARATION FOR USE IN UNSPECIFIED REPROCESSING PROCEDURES. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19614750 ↗
• MalfunctionJun 26, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE CONNECTING TUBE WERE BROKEN. IT WAS REPORTED THAT THE CONNECTOR'S RIGH AND LEFT LEG CONTINUED TO FALL OFF. IT WAS ALSO REPORTED THAT OER-ELITE ENDOSCOPE REPROCESSOR WAS INTERMITTENTLY RECEIVING AN EO61 ERROR CODE, THE ISSUE WAS DUE TO THE CONNECTING TUBE. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17203846 ↗
• MalfunctionJun 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT HIS OLYMPUS CONNECTING TUBES WERE BREAKING DURING REPROCESSING. ACCORDING TO THE INITIAL REPORTER, THE CONNECTOR¿S RIGHT AND LEFT LEGS WERE FALLING OFF. THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT. FOR REFERENCE TO RELATED EVENTS, PLEASE SEE REPORTS WITH THE FOLLOWING PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17143434 ↗
• 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-2330). (B)(6) (MODEL NUMBER: MAJ-2330): THIS REPORT. (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:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17043284 ↗
• 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): THIS REPORT (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: M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17042668 ↗
• MalfunctionMay 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, THE CONNECTING TUBE SIDE CONNECTORS CRACK AND FALL OFF. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS RELATED TO THE FOLLOWING PATIENT IDENTIFIERS: (B)(6) , (MAJ-2117). (B)(6) , (MAJ-2111). (B)(6) , (MAJ-2110). (B)(6) , (MAJ-2330, THIS REPORT). (B)(6) , (MAJ-2110).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17035125 ↗
• 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 17013823 ↗
• 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 17013281 ↗
• MalfunctionMar 31, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING REPROCESSING, THERE HAS BEEN AN ONGOING ISSUE WITH THE BROKEN CONNECTING TUBE WHILE BEING USED WITH THE OER-ELITE PREPROCESSOR. THE CONNECTORS ARE BREAKING ON THE PREPROCESSOR CONNECTOR SIDE. THE CONNECTING TUBE CANNOT BE CONNECTED TO THE CHANNEL CONNECTOR IN THE REPROCESSING BASIN. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16658847 ↗
• MalfunctionFeb 8, 2023Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THE SUBJECT DEVICE COULD NOT BE CONNECTED TO THE CHANNEL CONNECTOR 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 16330254 ↗
• MalfunctionFeb 8, 2023Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THE SUBJECT DEVICE COULD NOT BE CONNECTED TO THE CHANNEL CONNECTOR 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 16327257 ↗
• MalfunctionNov 19, 2022Separation Failure; Separation Failure

  CUSTOMER CONFIRMED ALL THE CONNECTORS BROKE AT THE METAL CLIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15831102 ↗

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