ULTRASONIC PROBE UM-S20-17S (REF N5386440)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of ULTRASONIC PROBE (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus UM-S20-17S ultrasonic probe has 24 adverse event reports, all malfunctions, with no deaths and no injuries. Reports mostly describe physical wear found during inspection, such as bent or kinked insertion tubes, scratches, chips, and torn material, nearly always with no patient involvement. Reports have risen sharply, with 23 filed in the latest 12 months versus 1 in the prior period. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04953170467301), received between Sep 4, 2025 and Sep 17, 2026 — classified as 18 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (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.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent4
- Material Deformation3
- Scratched Material3
- Break2
- Material Split, Cut or Torn2
- Contamination1
- Detachment of Device or Device Component1
- Device Contamination with Body Fluid1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- Insufficient Information1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Break
The customer reported the Ultrasonic Probe Tip was damaged. The issue was found During set up / Inspection for use (during set up in room / before patient in room).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50805861 ↗MalfunctionSep 2, 2026Device Contamination with Body Fluid
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50555946 ↗MalfunctionJun 11, 2026Material Deformation
THE CUSTOMER RETURNED THE ULTRASONIC PROBE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE IT WAS IDENTIFIED THE DEVICE HAD DAMAGE TO THE PROBE THAT MAY HAVE AFFECTED THE IMAGE GENERATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25471046 ↗MalfunctionJun 9, 2026Scratched Material
THE CUSTOMER RETURNED THE ULTRASONIC PROBE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE EVALUATION INDICATED THAT LIGHT SCRATCHES ALONG THE PROBE INSERTION TUBE WERE FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25448333 ↗MalfunctionJun 5, 2026Failure to Clean Adequately
THE CUSTOMER REPORTED THERE WAS BLOOD INSIDE THE PROBE DURING AN UNSPECIFIED PROCEDURE INVOLVING AN OLYMPUS ULTRASONIC PROBE. THE CUSTOMER REPORTED THE PROBE WAS CLEANED. THE TECHNICAL ASSISTANCE CENTER (TAC) REPRESENTATIVE RECOMMENDED PRESOAKING AND MANUALLY CLEANING THE PROBE IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE TO CLEAN THE BLOOD FROM THE DEVICE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25414708 ↗MalfunctionJun 4, 2026Material Twisted/Bent; Scratched Material
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE ULTRASONIC PROBE EXHIBITED LIGHT SCRATCHES ALONG THE PROBE INSERTION TUBE AND HAD A SLIGHT BEND. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25398970 ↗MalfunctionJun 3, 2026Material Twisted/Bent
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC PROBE HAD LIGHT BENDS ALONG THE PROBE INSERTION TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25385486 ↗MalfunctionMay 27, 2026Material Split, Cut or Torn
THE CUSTOMER RETURNED THE ULTRASONIC PROBE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE EVALUATION IDENTIFIED A DEEP CUT ON THE DISTAL TIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25311317 ↗MalfunctionApr 11, 2026Material Deformation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC PROBE'S INSERTION TUBE WAS KINKED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24847171 ↗MalfunctionApr 4, 2026Scratched Material
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE ULTRASONIC PROBE EXHIBITED A SCRATCHED INSERTION TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24784448 ↗MalfunctionApr 1, 2026Material Split, Cut or Torn
IT WAS REPORTED, THE ULTRASONIC PROBE EXHIBITED THERE WAS A SLICE/CUT IN THE RADIAL PROBE EXPOSING THE INTERNAL COMPONENT. THE EVENT OCCURRED DURING SET UP / INSPECTION FOR USE (DURING SET UP IN ROOM / BEFORE PATIENT IN ROOM). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24754638 ↗MalfunctionMar 25, 2026Material Deformation
IT WAS REPORTED THAT THE ULTRASONIC PROBE CABLE IS CRASHED; THE GRAY LIGHT CORD THAT COMES OUT WAS CRASHED. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENTS¿ HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24695151 ↗MalfunctionFeb 20, 2026Contamination
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24403514 ↗MalfunctionJan 7, 2026Detachment of Device or Device Component
IT WAS REPORTED THE ULTRASONIC PROBE TIP BROKE OFF. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23991370 ↗MalfunctionDec 9, 2025Device Reprocessing Problem; Device Reprocessing Problem
ADDITIONAL ISSUES/MALFUNCTIONS WERE FOUND DURING INVESTIGATION AND WERE IDENTIFIED/DETERMINED TO BE NOT REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23760235 ↗MalfunctionDec 1, 2025Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THE ULTRASONIC PROBE HAS A MICRO BREAK AT THE DISTAL TIP. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23680808 ↗MalfunctionNov 17, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE ULTRASONIC PROBE TWISTED INTO A KNOT DURING A THERAPEUTIC ROBOTIC BRONCHOSCOPY PROCEDURE AND COULD NOT BE USED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: Insufficient Information
MAUDE report 23573897 ↗MalfunctionSep 4, 2025Material Twisted/Bent; Material Twisted/Bent
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22964474 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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