ULTRASONIC PROBE UM-DP20-25R (UDI 04953170143663)Recalls & reported problems
Olympus Medical Systems Corp. · "N1027530 OLA UM-DP20-25R DUAL PLANE RECO" · Class 2
All models of ULTRASONIC PROBE (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170143663), received between Apr 18, 2024 and Mar 17, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Material Deformation1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2026Material Deformation; Material Twisted/Bent
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24616886 ↗MalfunctionJul 16, 2024Break; Break
IT WAS OBSERVED, THAT DURING, THE DEVICE EVALUATION. THE SUBJECT DEVICE EXHIBITED SCRATCHES ON THE PROBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19757467 ↗MalfunctionApr 18, 2024Break; Break
IT WAS REPORTED, THE ULTRASONIC PROBE HAD A DISTAL END CORE OF PROBE CANNOT BE RESET. IT COULD NOT RETURN TO ITS ORIGINAL POSITION AND NO IMAGE LOSS OCCURRED. THE ISSUE OCCURRED DURING CLEANING AND DISINFECTION. THE PROCEDURE WAS A DIAGNOSTIC ULTRASOUND EXAMINATION. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19135712 ↗
Other Endoscopic ultrasound system, gastroenterology-urology devices
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180Olympus Medical Systems Corp. · Endoscopic ultrasound system, gastroenterology-urology5 deaths2,392 reports
- PENTAX Medical EG38-J10UTHoya Corporation · Endoscopic Ultrasound System, Gastroenterology-Urology295 reports
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180Olympus Medical Systems Corp. · Endoscopic ultrasound system, gastroenterology-urology266 reports
- PENTAX EG-3870UTKHoya Corporation · Endoscopic ultrasound system, gastroenterology-urology164 reports
- PENTAX Medical EG36-J10URHoya Corporation · Endoscopic Ultrasound System, Gastroenterology-Urology126 reports
- PENTAX EG-3670URKHoya Corporation · Endoscopic ultrasound system, gastroenterology-urology72 reports
- PENTAX Medical EG34-J10UHoya Corporation · Endoscopic Ultrasound System, Gastroenterology-Urology61 reports
- BALLOON MAJ-1351Olympus Medical Systems Corp. · Endoscopic ultrasound system, gastroenterology-urology29 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page