CONNECTING TUBE MAJ-1513Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170234026), received between Sep 11, 2023 and Dec 17, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE CONNECTING TUBE FELL OFF DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23835323 ↗
• InjurySep 16, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DIAGNOSTIC PROCEDURE, A RUBBER -LIKE OBJECT ATTACHED TO THE FORCEPS PORT OF THE CONNECTING TUBE HAD FALLEN OFF INTO THE PATIENT. THE RUBBER FROM THE CLEANING TUBE HAS BEEN RETRIEVED. IT IS BELIEVED THAT THE RUBBER BROKE OFF WHEN CLEANING WITH A CLEANING DEVICE MADE BY ANOTHER COMPANY. THE RUBBER BROKE OFF AND ENTERED THE ENDOSCOPE, CAUSING IT TO FALL OFF DURING THE EXAMINATION. THE FRAGMENTS WERE RETRIEVED USING THE SAME DEVICE, AND THE PROCEDURE WAS COMPLETED (WITH THE SAME DEVICE). NO REPORTS OF HEALTH HAZARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20225004 ↗
• MalfunctionSep 11, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE EVIS EXERA III BRONCHOVIDEOSCOPE WAS ATTEMPTED TO BE REPROCESSED ON THE OER-PRO ENDOSCOPE REPROCESSOR, BUT THE MAJ-1513/CONNECTING TUBE WOULD NOT STAY CONNECTED TO THE SCOPE. IN SPEAKING WITH OLYMPUS TECHNICAL ASSISTANCE SUPPORT (TAC) VIA PHONE, THE CUSTOMER NOTED THAT WHEN THE REPROCESSING SEQUENCE WAS COMPLETED, THE CONNECTOR HAD COME OFF THE SCOPE. THE CONNECTING TUBE COULD NOT BE CONNECTED TO THE CHANNEL CONNECTOR IN THE REPROCESSING BASIN. THE CUSTOMER ONLY HAD ONE BF-P190 SCOPE AND ONE MAJ-1513 CONNECTING TUBE. THE PRODUCT WILL NOT BE RETURNED. THERE WERE NO REPORTS OF PATIENT HARM. RELATED PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17720728 ↗