SINGLE USE BIOPSY VALVE MAJ-1555Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 14953170247573), received between Dec 13, 2020 and Jul 1, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THERAPEUTIC MUCOSECTOMY/POLYPECTOMY THE INTERNAL RUBBER FALLS OFF EASILY DURING PROCEDURES. WHEN IT IS IN USE, THE DOCTOR HAS TO INSERT AND REMOVE NEEDLES, CLAMPS, SNARES, ETC, FROM THE WORKING CHANNEL MANY TIMES. THIS FRICTION ENDS UP DETACHING THE RUBBER AND PUSHING IT THROUGH THE WORKING CHANNEL. IN ONE CASE, IT FELL INTO THE PATIENT'S COLON AND THE DOCTOR HAD TO "HUNT" IT DOWN AND REMOVE IT WITH FORCEPS. THERE WAS NO REPORTED INJURY OR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19650325 ↗
• MalfunctionMar 27, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT DURING REPROCESSING, THIS SINGLE USE BIOPSY VALVE, GOT STUCK IN BIOPSY CHANNEL. IT WAS IDENTIFIED THAT THE STAFF WAS REUSING THE VALVES WHICH IS AFFECTING THE INTEGRITY OF THE DEVICE. THE STAFF, DOCTORS, BIOMEDICAL AND WARD MANAGER WERE CONSIDERING TO START USING REUSABLE VALVES. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16624414 ↗
• MalfunctionOct 11, 2022Fitting Problem; Fitting Problem

  THE CUSTOMER REPORTED DISSATISFACTION WITH THE FUNCTIONALITY OF THE SUBJECT DEVICE (BIOPSY VALVE). IT WAS REPORTED THE VALVE WOULD NOT FIT THE LUER LOCK SYRINGE AND WHEN USING IT WITH A POINTED SYRINGE THE WATER WOULD COME OUT FROM ALL SIDES WHICH MEANS THAT WATER CANNOT BE IRRIGATED THROUGH THE CHANNEL, PREVENTING THE CORRECT CLEANING OF THE MUCOSA TO CONTINUE THE PROCEDURE. THE REPORTED ISSUE OCCURRED DURING AN UNSPECIFIED DIAGNOSTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING THE SUBJECT DEVICE. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT. THIS REPORT IS BEING SUBMITTED DUE TO WATER COMING OUT OF THE BIOPSY VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15583893 ↗
• MalfunctionMar 2, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE USER FACILITY REQUESTED A REPROCESSING IN-SERVICE FOR THE SINGLE USE BIOPSY VALVE (STERILE). AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) VISITED THE CUSTOMER AND NOTED DURING THE IN-SERVICE, THE CUSTOMER WAS NOT DISCARDING SINGLE USE BIOPSY BUT INSTEAD REPROCESSING THEM. IT WAS REPORTED THAT THE CUSTOMER WAS NOT USING MH-948 ENDOSCOPE AW CHANNEL CLEANING ADAPTER FOR PRECLEANING OF EQUIPMENT. THERE WAS NO PATIENT INVOLVEMENT, NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. ADDITIONAL INFORMATION FROM THE USER FACILITY CONFIRMED THAT THE BIOPSY CHANNEL COVERS WERE CLEANED AND STERILIZED FOR REPROCESS TRAINING PURPOSES AND THE BIOPSY CHANNEL COVERS WERE NOT REUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13653764 ↗
• MalfunctionDec 13, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT THE SUBJECT DEVICE OPENED EASILY DURING AN UNSPECIFIED PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10999771 ↗