ULTRASONIC PROBE UM-2R (UDI 04953170368554)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04953170368554), received between Jan 28, 2021 and Oct 9, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2024Break; Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBIT PROBE BREAKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20406550 ↗
• MalfunctionSep 24, 2024Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20294959 ↗
• MalfunctionSep 9, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A BENDING INSERTION PART. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20168247 ↗
• MalfunctionJul 10, 2024Material Deformation; Material Deformation

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC PROBE EXHIBITED FLEXION OF THE INSERTION TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19714589 ↗
• MalfunctionJun 20, 2024Material Deformation; Material Deformation

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC PROBE EXHIBITED A WRINKLE AND SCRATCHES ON THE INSERTION TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19575490 ↗
• MalfunctionMay 16, 2024Contamination; Contamination

  IT WAS REPORTED THAT AFTER CLEANING AND DISINFECTING THE ULTRASONIC PROBE, A BLACK LIQUID CAME OUT FROM THE BLACK PART THAT CONNECTS TO THE DRIVE UNIT AFTER IT WAS REMOVED FROM THE CLEANING MACHINE. THE ISSUE WAS FOUND DURING REPROCESSING AND THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19330439 ↗
• MalfunctionMay 6, 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 PROBE AND INSERTION BREAKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19248258 ↗
• MalfunctionJan 28, 2021Device Reprocessing Problem; Device Reprocessing Problem

  THE SERVICE CENTER WAS INFORM THAT DURING AN ONSITE EDUCATION TRAINING WITH AN ENDOSCOPY SUPPORT SPECIALIST (ESS) IT WAS NOTED THAT THE FACILITYS STAFF WAS IMPROPERLY REPROCESSING THE ULTRASONIC PROBE. THERE WAS NO PATIENT INFECTION OR PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 11244233 ↗