CONNECTING TUBE MAJ-1516Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170234057), received between Aug 3, 2020 and Jun 28, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE FIELD SERVICE ENGINEER OF OLYMPUS, THAT IT WAS FOUND A PIN INSIDE THE EQUIPMENT SIDE CONNECTOR (RESIN) OF THE SUBJECT DEVICE WAS BROKEN AND HAD BEEN GONE WHEN VISITING THE USER FACILITY. THE SUBJECT DEVICE HAD BEEN USED WITH AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL OER-5. IT WAS UNKNOWN WHEN THE ISSUE HAD BEEN OCCURRED. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12075359 ↗
• MalfunctionAug 3, 2020Mechanical Problem; Mechanical Problem

  DURING INSPECTION PRIOR TO USE, THE DEVICE'S LOCK LEVER DIDN'T FIT IN WITH AUTOMATED ENDOSCOPE REPROCESSOR. THE CUSTOMER USED ANOTHER CONNECTING TUBE TO COMPLETE THE REPROCESSING. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10360192 ↗