ULTRASONIC PROBE UM-S20-20R (UDI 04953170078705)Recalls & reported problems
Olympus Medical Systems Corp. · OLA ONLY UM-S20-20R-3 SLIM 20 MHZ PROBE · Class 2
All models of ULTRASONIC PROBE (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170078705), received between Aug 7, 2020 and Dec 13, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination” (1 report).
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
- Contamination1
- Dent in Material1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 13, 2024Dent in Material; Material Twisted/Bent; Dent in Material; Material Twisted/Bent
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED DENT IN THE DISTAL SHEATH AND THE INSERTION SHEATH WAS CRUSHED AND HAD A KINK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20924912 ↗MalfunctionAug 7, 2020Contamination; Contamination
THE SERVICE CENTER WAS INFORMED THAT BLOOD WAS DISCOVERED APPROXIMATELY 1.5 INCH FROM THE TIP INSIDE THE CASING OF THE PROBE. THE CUSTOMER REPORTED THAT THE BLOOD WAS DISCOVERED AFTER THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: Patient Problem/Medical Problem
MAUDE report 10381981 ↗
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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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