ULTRASONIC PROBE UM-3R (UDI 04953170368561)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04953170368561), received between Jan 13, 2021 and Apr 9, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Detachment of Device or Device Component; Material Deformation

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE ULTRASONIC PROBE EXHIBITED FOUND LOCK PIN WAS DAMAGED WITH CHIP OFF AND FOUND MANY KINKS ON THE PROBE¿S CABLE UNIT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24835014 ↗
• MalfunctionJan 2, 2026Break

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE ULTRASONIC PROBE EXHIBITED THE DISTAL END WAS DAMAGED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23943135 ↗
• MalfunctionDec 17, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THE ULTRASONIC PROBE HAD A LEAKAGE AT THE DISTAL END OF THE SENSOR. THE ISSUE OCCURRED DURING THE SET-UP. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830266 ↗
• MalfunctionSep 9, 2025Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE ULTRASONIC PROBE EXHIBITED A PINHOLE IN THE SHEATH IN THE DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23009273 ↗
• MalfunctionJul 11, 2025Material Frayed; Detachment of Device or Device Component; Material Split, Cut or Torn; Material Frayed; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING INSPECTION FOR USE, THE PLASTIC COVERING ON THE ULTRASONIC PROBE WAS PULLED APART, AND IT WAS NOTED THAT THE WIRES WERE FRAYED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22485449 ↗
• MalfunctionDec 9, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED BEND IN THE INSERTION SHEATH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878829 ↗
• MalfunctionNov 5, 2024Fracture; Fracture

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC PROBE EXHIBITED A FRACTURE AT THE DISTAL END OF THE TRANSDUCER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20609942 ↗
• MalfunctionOct 3, 2024Material Deformation; Material Deformation

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, AN INDENTATION AT THE TIP OF THE INSERTION PART WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20364065 ↗
• MalfunctionSep 16, 2024Material Deformation; Scratched Material; Material Deformation; Scratched Material

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC PROBE EXHIBITED SCRATCHES ON THE INSERTION SITE AND BENDING OF THE INSERTION TIP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20226541 ↗
• MalfunctionAug 27, 2024Material Deformation; Material Deformation

  IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE ULTRASONIC PROBE HAD WRINKLES AT THE INSERTION SITE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20081721 ↗
• MalfunctionAug 6, 2024Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC PROBE EXHIBITED ULTRASONIC MEDIA LEAKAGE DUE TO TIP PART BREAKAGE (HOLE). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19919462 ↗
• MalfunctionJul 22, 2024Scratched Material; Scratched Material

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED SCRATCHES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19799906 ↗
• MalfunctionJun 28, 2024Stretched; Deformation Due to Compressive Stress; Stretched; Deformation Due to Compressive Stress

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED INDENTATION AND ELONGATION AT THE TIP OF THE INSERTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19639349 ↗
• MalfunctionJun 21, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED DURING A DIAGNOSTIC PROCEDURE THE SUBJECT DEVICE HAD A LEAKAGE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19581600 ↗
• MalfunctionMay 10, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC PROBE EXHIBITED TWISTING OF THE INSERTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19286814 ↗
• MalfunctionMay 6, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT ULTRASOUND PROBE HAD A TEAR AT THE TIP OF THE INSERT AND LEAKAGE OF ULTRASOUND MEDIUM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19247094 ↗
• MalfunctionMar 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT WHEN PREPARING THE SUBJECT DEVICE FOR USE, THE ULTRASOUND IMAGE WAS ABNORMAL. THERE WAS NO REPORT OF PATIENT/USER HARM OR INJURY DUE TO THE EVENT. THE DEVICE WAS SENT TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. DEVICE INSPECTION AND TESTING CONFIRMED THE REPORTED IMAGE ISSUE. IN ADDITION, SERVICE OBSERVED ULTRASONIC MEDIUM (OIL) LEAKING FROM THE INSERTION TUBE. THIS REPORT IS BEING SUBMITTED FOR THE REPORTABLE MALFUNCTION OF THE ULTRASONIC MEDIUM LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13763038 ↗
• MalfunctionJan 13, 2021Fluid/Blood Leak; Material Twisted/Bent; Fluid/Blood Leak; Material Twisted/Bent

  IT WAS REPORTED THERE WAS OIL LEAKING FROM THE TIP OF THE ULTRASONIC PROBE. NO PATIENT HARM OR IMPACT WAS REPORTED DUE TO THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11158521 ↗