Biopsy Valve MAJ-579Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04953170061516), received between May 13, 2022 and Oct 15, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED, THE BIOPSY VALVE ACCESSORY WAS INCORRECTLY REPROCESSED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20456363 ↗
• MalfunctionOct 15, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED, THE BIOPSY VALVE WAS INCORRECTLY REPROCESSED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: Bacterial Infection

  MAUDE report 20455444 ↗
• MalfunctionOct 15, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED, THE BIOPSY VALVE ACCESSORY WAS INCORRECTLY REPROCESSED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20454357 ↗
• MalfunctionOct 11, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE BIOPSY VALVE WAS INCORRECTLY REPROCESSED. THE FACILITY WAS INTERVIEWED BY THE OLYMPUS REPRESENTATIVES AND STATED DEVIATION FROM THE REPROCESSING GUIDELINES. THE ISSUE OCCURRED DURING AN UNKNOWN EVENT AND PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20434235 ↗
• MalfunctionOct 11, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THE BIOPSY VALVE WAS INCORRECTLY REPROCESSED. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20434034 ↗
• MalfunctionOct 11, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THE BIOPSY VALVE WAS INCORRECTLY REPROCESSED. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20433871 ↗
• MalfunctionOct 11, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THE BIOPSY VALVE REPROCESSING WAS DEVIATED FROM THE REPROCESSING GUIDELINES. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20432977 ↗
• MalfunctionOct 11, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THE BIOPSY VALVE REPROCESSING WAS DEVIATED FROM THE REPROCESSING GUIDELINES. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20432851 ↗
• MalfunctionOct 11, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THE BIOPSY VALVE REPROCESSING WAS DEVIATED FROM THE REPROCESSING GUIDELINES. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20432288 ↗
• MalfunctionMay 13, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT WHILE USING AN OLYMPUS BIOPSY VALVE DURING A UROLOGY OUTPATIENT PROCEDURE, WATER BEGAN LEAKING FROM THE HEAD OF THE T-SHAPED TUBING. UPON CLOSER INSPECTION, THE USER NOTED A CRACK IN THE VALVE. ACCORDING TO THE INITIAL REPORTER, THE PROCEDURE WAS COMPLETED USING THE SUBJECT DEVICE. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14395673 ↗