CONNECTING TUBE MAJ-2115Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04953170404108), received between Nov 19, 2022 and Apr 10, 2024 — classified as 8 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

   XXX

   Z-1903-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2024Break; Break

  AN OLYMPUS REPRESENTATIVE REPORTED THAT THE CONNECTOR TUBE OF THE REPROCESSOR 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 19078545 ↗
• MalfunctionOct 30, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D) DEVICE WAS SEEN IN CLINIC. PROGRAMMING WAS PERFORMED TO PACE FASTER THAN THE CURRENT RATE TO SLOW DOWN VENTRICULAR TACHYCARDIA (VT). THERE WERE STORED EPISODES OF PACEMAKER MEDIATED TACHYCARDIA (PMT) WHICH WERE DETERMINED TO NOT BE TRUE PMT RATHER THE PATIENT'S SLOW VENTRICULAR TACHYCARDIA (VT). THE PATIENT HAD A SICK HEART, AND THE ATRIUM APPEARED TO BE DRIVING THE RATES. TS RECOMMENDED THAT RECOMMENDED THAT THE PMT ALGORITHM TO BE PROGRAMMED OFF AND THAT THE PATIENT'S ATRIAL RATE NEEDS TO BE ADDRESSED BY THE FOLLOWING PHYSICIAN. THIS DEVICE CURRENTLY REMAINS IN SERVICE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS SEEN IN THE CLINIC WITH THE HISTORY OF SLOW VT. DURING THE VISIT IN CLINIC, THERE WAS GOOD CAPTURE ON RV AND LV LEADS. TECHNICAL SERVICES (TS) REVIEWED AND STATED THAT RV SENSE GOT CLOSE ENOUGH TO THE AP-SR THAT IT FALLS INTO CROSS CHAMBER BLANKING PERIOD [RV] AND IS FUNCTIONALLY UNDERSENSED AND THERE WAS FUNCTIONAL LOSS OF CAPTURE (LOC). TS STATED THAT THERE WAS NORMAL OPERATION WITH JUST THE PRODUCT OF THE TIMING AND T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18029502 ↗
• 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 4 OF 14. PLEASE SEE THE FOLLOWING PATIENT IDENTIFIERS FOR THE RELATED EVENTS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18029427 ↗
• 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). (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 17086535 ↗
• 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): THIS REPORT. (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 17086399 ↗
• 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): THIS REPORT; (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 17085896 ↗
• 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): THIS REPORT, (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 17085823 ↗
• MalfunctionNov 19, 2022Separation Problem; Separation Problem

  CUSTOMER CONFIRMED ALL THE CONNECTORS BROKE AT THE METAL CLIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15831088 ↗

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