ULTRASONIC PROBE UM-DG20-31RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170368462), received between Nov 11, 2022 and Nov 1, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Body Fluid” (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.

• MalfunctionNov 1, 2023Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING PRE-USE INSPECTION, WHEN THE CUSTOMER CONNECTED THE ULTRASONIC PROBE, WHICH HAD BEEN USED ABOUT 5 TIMES, TO THE DRIVE UNIT (MAJ-935), THE CUSTOMER WAS UNABLE TO CONNECT IT PROPERLY, DUE TO THE PART THAT BEING STUCK INTO THE DRIVE UNIT WAS STARTING TO COME OFF. THE DOCTOR REPLACED IT WITH ANOTHER PRODUCT AND COMPLETED THE PROCEDURE. NO EFFECT ON THE PATIENT. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION, AND THE EVALUATION FOUND THAT THERE IS LEAKAGE OF ULTRASOUND MEDIUM FROM INSERTION TUBE. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18046988 ↗
• MalfunctionNov 11, 2022Fluid/Blood Leak; Material Puncture/Hole; Device Contamination with Body Fluid; Fluid/Blood Leak; Material Puncture/Hole; Device Contamination with Body Fluid

  THE CUSTOMER REPORTED THAT, DURING PREPARATION FOR USE, THE ULTRASOUND ECHO IMAGE FROM THE SUBJECT DEVICE WAS DISTORTED. THE PLANNED PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE. THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT. THE SUBJECT DEVICE WAS SENT TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING, THERE WAS LEAKAGE OF THE ULTRASONIC MEDIUM FROM THE INSERTION TUBE AND BLOOD HAD INFILTRATED THE INSIDE OF THE TIP SHEATH. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (LEAKAGE OF ULTRASONIC MEDIUM AND INFILTRATION OF BLOOD).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15780659 ↗