ULTRASONIC PROBE UM-S20-17S (UDI 04953170368479)Recalls & reported problems
Olympus Medical Systems Corp. · "UM-S20-17S ULTRASONIC PROBE" · Class 2
All models of ULTRASONIC PROBE (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus ultrasonic probe is a diagnostic ultrasound transducer. Of its 351 reports, 325 describe malfunctions and 24 describe injuries, while 2 mention deaths. Many describe breaks, leaks, or bent and split parts, and 11 mention a collapsed lung, although most report no patient symptoms. 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
- 344
- Deaths reported
- 2
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 344 adverse event reports that list this exact device (DI 04953170368479), received between Sep 18, 2018 and Sep 23, 2026 — classified as 2 deaths, 24 injuries, 318 malfunctions.
The most frequently reported specific device problem is “Break” (60 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
- Break60
- Leak/Splash45
- Material Deformation41
- Material Twisted/Bent34
- Material Split, Cut or Torn26
- Detachment of Device or Device Component24
- Fluid/Blood Leak22
- Deformation Due to Compressive Stress20
Patient problems
- No Clinical Signs, Symptoms or Conditions322
- Pneumothorax11
- Hemorrhage/Blood Loss/Bleeding9
- No Consequences Or Impact To Patient3
- Pneumonia3
- Cardiac Arrest2
- Fever2
- Foreign Body In Patient2
Recent adverse event reports
The 25 most recent of 344 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Leak/Splash; Material Deformation
The customer returned the ULTRASONIC PROBE to the service center for a separate issue. During Olympus¿ device analysis it was indicated that the ULTRASONIC PROBE had a crushed insertion sheath and a leak in the ultrasonic medium. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863367 ↗MalfunctionSep 17, 2026Deformation Due to Compressive Stress
The customer reported the Ultrasonic Probe cable unit on the probe had a kink on it. IT was not specified during what type of device usage the reported event occurred. There was no reported patient injury or medical intervention associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50805795 ↗MalfunctionJul 28, 2026Break
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50054818 ↗MalfunctionJun 11, 2026Material Split, Cut or Torn
THE CUSTOMER RETURNED THE ULTRASONIC PROBE, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, HOUSING FOUND A CUT MARK OR PUNCTURE ON THE PROBES CABLE UNIT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25471020 ↗MalfunctionJun 9, 2026Scratched Material
THE CUSTOMER RETURNED THE ULTRASONIC PROBE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED A SCRATCH MARK NEAR THE PROBE TIP WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25442214 ↗MalfunctionMay 29, 2026Material Twisted/Bent; Scratched Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC PROBE CABLE UNIT HAD SCRATCH MARKS, AND THE PROBE TIP WAS BENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25333210 ↗MalfunctionMay 28, 2026Crack; Material Split, Cut or Torn
IT WAS REPORTED THE ULTRASONIC PROBE HAD A CRACK IN OUTER SHEATH. THE ISSUE WAS DISCOVERED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25323169 ↗MalfunctionMay 12, 2026Crack; Fluid/Blood Leak; Material Deformation
DURING THE DEVICE EVALUATION, A CRACK WAS IDENTIFIED IN THE CABLE UNIT OF THE ULTRASONIC PROBE, WHICH ALLOWED INTERNAL OIL TO LEAK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25156287 ↗MalfunctionMay 4, 2026Material Deformation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC PROBE HAD CRITICAL KINKS ON PROBE¿S CABLE UNIT THAT CAUSED PROBE TO SHAKE VIGOROUSLY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25070236 ↗MalfunctionMay 4, 2026Gas/Air Leak; Material Split, Cut or Torn
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE ULTRASONIC PROBE EXHIBITED A CUT MARK ON PROBE¿S CABLE UNIT, AND INTERNAL OIL WAS LEAKED OUT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25069353 ↗MalfunctionApr 24, 2026Burst Container or Vessel; Leak/Splash
IT WAS REPORTED THE ULTRASONIC PROBE MINI-PROBE BURST AND WAS REMOVED AFTER BEING INSERTED FIVE TIMES. THE ISSUE OCCURRED DURING A DIAGNOSTIC BRONCHOSCOPY WITH AN ULTRASOUND MINI-PROBE. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24988005 ↗MalfunctionApr 22, 2026Material Twisted/Bent; Material Split, Cut or Torn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC PROBE HAD A CUT ON THE PROBE CABLE AND A BENT PROBE TIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24955525 ↗MalfunctionApr 22, 2026Material Separation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC PROBE INTERNAL SHAFT WAS SEPARATED FROM DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24954253 ↗MalfunctionApr 17, 2026No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE ULTRASONIC PROBE EXHIBITED MANY KINKS ON PROBE¿S CABLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24915937 ↗MalfunctionApr 17, 2026Material Deformation; Unintended Movement
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC PROBE EXHIBITED KINKS ON PROBE¿S CABLE UNIT AND THE PROBE IS PHYSICALLY SHAKING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912379 ↗MalfunctionApr 17, 2026Deformation Due to Compressive Stress
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC PROBE HAD KINKS ON THE PROBE'S CABLE SECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24911414 ↗MalfunctionApr 17, 2026Material Twisted/Bent; Material Split, Cut or Torn
IT WAS REPORTED, THE ULTRASONIC PROBE EXHIBITED THE END WAS BENT/BROKEN. UNSURE AS TO WHEN THE EVENT OCCURRED. THERE WAS NO REPORT OF HARM, INJURY OR DEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24911366 ↗MalfunctionApr 16, 2026Material Twisted/Bent
IT WAS REPORTED, THE ULTRASONIC PROBE EXHIBITED A KINK WHEN IT WAS TAKEN OUT OF THE BOX BEFORE REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24895941 ↗MalfunctionApr 14, 2026Material Twisted/Bent
IT WAS REPORTED THE ULTRASONIC PROBE EXHIBITED THE PROBE WAS BENT WHEN THE CUSTOMER OPENED THE BOX. THIS WAS AN OUT OF BOX FAILURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24877119 ↗MalfunctionApr 13, 2026Material Deformation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC PROBE EXHIBITED MANY KINKS ON PROBE¿S CABLE UNIT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24865226 ↗MalfunctionApr 11, 2026Dent in Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC PROBE HAD A DAMAGED OUTER SHEATH TIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24846228 ↗MalfunctionApr 10, 2026Detachment of Device or Device Component
IT WAS OBSERVED DURING OLYMPUS' DEVICE INSPECTION THAT THE ULTRASONIC PROBE'S LOCK PIN WAS CHIPPED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24845335 ↗MalfunctionApr 10, 2026Unstable; Material Deformation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC PROBE HAD KINKS ON THE CABLE UNIT THAT CAUSED THE PROBE TO SHAKE ABNORMALLY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24843982 ↗MalfunctionApr 8, 2026Material Deformation
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE ULTRASONIC PROBE EXHIBITED FOUND SOME KINKS ON THE CABLE UNIT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24821456 ↗MalfunctionApr 8, 2026Material Split, Cut or Torn
DURING THE DEVICE EVALUATION, A CUT WAS FOUND ON THE ULTRASONIC PROBE CABLE UNIT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24818614 ↗
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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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