ULTRASONIC PROBE UM-G20-29R (UDI 04953170368578)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04953170368578), received between Jan 17, 2023 and Jan 14, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2026Material Twisted/Bent

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC PROBE EXHIBITED THE INSERTION SECTION SHEATH WAS TWISTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068063 ↗
• MalfunctionSep 16, 2025Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE [PRODUCT] EXHIBITED THE DISTAL END SHEATH WAS DAMAGED (PINHOLE) AND THERE WAS LEAKAGE OF ULTRASOUND MEDIA. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23069737 ↗
• MalfunctionApr 3, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THE ULTRASONIC PROBE'S INSERTION TUBE SHEATH AND CONNECTOR SHEATH BECAME TWISTED DURING A DIAGNOSTIC INTRADUCTAL ULTRASONOGRAPHY. THE PROCEDURE WAS COMPLETED BY REPLACING THE DEVICE WITH A SIMILAR DEVICE. THERE WAS NO DELAY, PATIENT INJURY, NOR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21764655 ↗
• MalfunctionMar 25, 2025Residue After Decontamination; Contamination /Decontamination Problem; Residue After Decontamination; Contamination /Decontamination Problem

  NO ADDITIONAL CUSTOMER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21689155 ↗
• MalfunctionDec 9, 2024Break; Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A BROKEN ULTRASOUND PROBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20880005 ↗
• MalfunctionDec 6, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS OBSERVED, THAT DURING THE DEVICE EVALUATION. THE SUBJECT DEVICE EXHIBITED CONTINUOUS BUCKLING OF THE INSERTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860916 ↗
• MalfunctionNov 14, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS OBSERVED, THAT DURING THE DEVICE EVALUATION. THE SUBJECT DEVICE EXHIBITED DAMAGE (TORN) AT THE INSERTION PART. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685362 ↗
• MalfunctionNov 13, 2024Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20673649 ↗
• MalfunctionSep 24, 2024Break; Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED DAMAGE TO THE ULTRASONIC PROBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20294321 ↗
• MalfunctionJul 23, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19812469 ↗
• MalfunctionJun 21, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC PROBE EXHIBITED DENTS AT THE TIP OF THE INSERTION PART AND PROBE DAMAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19580292 ↗
• MalfunctionMay 23, 2024Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED DAMAGE TO THE ULTRASOUND PROBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19387121 ↗
• MalfunctionMay 23, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19386533 ↗
• MalfunctionMay 21, 2024Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19367991 ↗
• MalfunctionMay 3, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE SUBJECT DEVICE WAS INSERTED INTO THE DRIVE UNIT (PROCESSOR), HOWEVER, NO ULTRASOUND IMAGES WERE PRODUCED. THIS WAS DISCOVERED DURING A PRE-USE INSPECTION. THE DEVICE WAS REPLACED AND THE INTENDED DIAGNOSTIC PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO PATIENT IMPACT, NO HARM REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19244240 ↗
• MalfunctionApr 8, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC PROBE EXHIBITED TEAR AT THE TIP OF THE INSERT AND LEAKAGE OF ULTRASOUND MEDIA. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19068326 ↗
• MalfunctionFeb 27, 2024No Display/Image; No Display/Image

  IT WAS REPORTED, THE SUBJECT DEVICE HAD AN ECHO IMAGE THAT DID NOT APPEAR. THE ISSUE OCCURRED DURING A DIAGNOSTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE THAT WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18794595 ↗
• MalfunctionNov 28, 2023Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED IT WAS DIFFICULT TO SEE THE ULTRASOUND IMAGES USING THE ULTRASONIC PROBE. THEY ADJUSTED THE SETTINGS AND USED IT TO COMPLETE THE UNSPECIFIED PROCEDURE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, LEAKAGE OF THE ULTRASOUND MEDIA WAS FOUND. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18215875 ↗
• MalfunctionJan 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT, DURING PREPARATION OF THE SUBJECT DEVICE FOR USE, MANY AIR BUBBLES WERE GENERATED AT THE TIP OF THE PROBE AND THE IMAGE COULD NOT BE SEEN DUE TO THE AIR BUBBLES. THE USER TRIED REMOVING THE AIR BUBBLES AS DESCRIBED IN THE INSTRUCTION MANUAL BUT THEY DID NOT DISAPPEAR. THE PROCEDURE WAS CHANGED TO ONE THAT DID NOT REQUIRE A PROBE AND WAS COMPLETED WITH NO IMPACT ON THE PATIENT. THE SUBJECT DEVICE WAS SENT TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. DURING INSPECTION AND TESTING, ULTRASONIC MEDIUM WAS LEAKING FROM THE INSERTION TUBE. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (LEAK).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16185509 ↗