CONNECTING TUBE MAJ-2116Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170404115), received between Jun 8, 2023 and Jun 9, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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-1904-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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-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 17097090 ↗
• 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-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 17097058 ↗
• 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): THIS REPORT, (B)(6) (MODEL NUMBER: MAJ-2116), (B)(6) (MODEL NUMBER:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097039 ↗
• 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-2114); (B)(6) (MODEL NUMBER: MAJ-2116): THIS REPORT; (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 17087350 ↗

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