ULTRASONIC PROBE UM-2R (UDI 04953170063206)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170063206), received between Nov 17, 2022 and Apr 22, 2026 — classified as 4 malfunctions.

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

• MalfunctionApr 22, 2026Material Twisted/Bent

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24955080 ↗
• MalfunctionMar 17, 2026Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THE ULTRASONIC PROBE WAS KINKED. THE ISSUE OCCURRED DURING MAINTENANCE OF THE DEVICE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617194 ↗
• MalfunctionAug 17, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE OLYMPUS MEDICAL SERVICE DEPARTMENT DETERMINED THAT THE CUSTOMER WAS MISSING A REQUIRED COMPONENT DURING REPROCESSING OF THE ULTRASONIC PROBE WHILE USING AN OLYMPUS ENDOSCOPE REPROCESSOR (OER-3). THE ISSUE WAS IDENTIFIED DURING REPROCESSING OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM HAS BEEN REPORTED. THE OER-3 OLYMPUS ENDOSCOPE REPROCESSOR WAS REPORTED IN THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17565504 ↗
• MalfunctionNov 17, 2022No Display/Image; No Display/Image

  WHILE AN OLYMPUS FIELD SERVICE ENGINEER (FSE) WAS AT THE USER¿S FACILITY, HE REPORTED THAT THE CUSTOMER¿S ULTRASONIC PROBE WAS NOT PRODUCING AN IMAGE DURING A PROCEDURE. ACCORDING TO THE FSE, THE CUSTOMER FINISHED THE PROCEDURE USING ANOTHER DEVICE WITH MINIMAL DELAYS AND NO PATIENT HARM. DURING THE DEVICE EVALUATION, IT WAS DISCOVERED THAT THERE WAS A BREAKAGE IN THE INSERTION TUBE. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE DAMAGE FOUND IN THE INSERTION TUBE DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15814332 ↗