ULTRASONIC PROBE UM-3R (UDI 04953170063213)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04953170063213), received between Dec 22, 2020 and Mar 27, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT AFTER THE ULTRASONIC PROBE WAS CLEANED AND DISINFECTED DURING REPROCESSING, YELLOW LIQUID ADHERED WHEN THE PROBE DEVICE WAS WIPED WITH GAUZE. THE YELLOW LIQUID ADHERED EVEN AFTER WIPING IT OFF SEVERAL TIMES. THE FACILITY'S CLEANING METHOD IS AS FOLLOWS: CLEANING USING ENDOPURE, IMMERSION IN DISOPA, FLUSHING WITH WATER, AND WIPING WITH DISINFECTANT ETHANOL SOLUTION B IP ON GAUZE. YELLOW LIQUID ADHERED AT THE LAST STEP IN THE CLEANING PROCESS. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO REPORT THE DEVICE WAS USED IN A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21712275 ↗
• MalfunctionDec 5, 2024Crack; Crack

  IT WAS REPORTED THAT ULTRASONIC PROBE HAD A CRACK ON ITS EXTERIOR, LOCATED MIDWAY ALONG THE PROBE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20855232 ↗
• MalfunctionMar 21, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, DURING MAINTENANCE, THE ULTRASONIC PROBE HAD DEFECTIVE IMAGE. UPON INSPECTION OF THE CUSTOMER¿S RETURNED DEVICE IT WAS OBSERVED, BREAKAGE OF THE INSERTION TUBE WAS NOTED. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16584813 ↗
• MalfunctionDec 7, 2022Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER, THE ULTRASONIC PROBE ULTRASOUND IMAGES ARE UNCLEAR AND DIFFICULT TO SEE DURING SURGERY. THE FREQUENCY IS NOT HIGH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. DURING INCOMING INSPECTION, IT WAS DETERMINED THERE WAS LEAKAGE IN THE ULTRASONIC MEDIUM DUE TO PERFORATION IN THE TIP SHEATH. THIS MEDWATCH IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15933607 ↗
• MalfunctionApr 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT WHEN PREPARING THE DEVICE FOR USE DURING A DIAGNOSTIC ULTRASONOGRAPHY PROCEDURE, THE SUBJECT DEVICE HAD A LEAKAGE OF ULTRASONIC MEDIUM FROM THE INSERTION TUBE. THE ISSUE WAS IDENTIFIED DURING THE FIRST USE AFTER DELIVERY TO THE FACILITY. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14018409 ↗
• MalfunctionDec 22, 2020Break; Break

  THE CUSTOMER FOUND FLUID COMING OUT OF THE DISTAL TIP OF THE DEVICE, WHICH WAS AT THE STORAGE AREA. THIS IS A SIGN OF DEVICE BREAKAGE. OTHER DETAILED INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11061596 ↗