ULTRASONIC PROBERecalls & reported problems across all models
Olympus Medical Systems Corp. · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 483
- Deaths reported
- 2
- Injuries reported
- 30
- Recalls
- 0
We found 17 models of ULTRASONIC PROBE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 483 adverse event reports in the FDA's MAUDE database, received between Sep 18, 2018 and Sep 23, 2026 — classified as 2 deaths, 30 injuries, 451 malfunctions.
The most frequently reported specific device problem is “Break” (96 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ULTRASONIC PROBE problems
Device problems
- Break96
- Leak/Splash60
- Material Deformation60
- Material Twisted/Bent49
- Fluid/Blood Leak36
- Material Split, Cut or Torn35
- Detachment of Device or Device Component30
- Deformation Due to Compressive Stress29
Patient problems
- No Clinical Signs, Symptoms or Conditions448
- Pneumothorax12
- Hemorrhage/Blood Loss/Bleeding11
- No Consequences Or Impact To Patient8
- Foreign Body In Patient3
- No Patient Involvement3
- Pneumonia3
- Cardiac Arrest2
ULTRASONIC PROBE models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ULTRASONIC PROBE UM-S20-17STransducer, ultrasonic, diagnostic2 deaths344 reports
- ULTRASONIC PROBE UM-G20-29RTransducer, ultrasonic, diagnostic20 reports
- ULTRASONIC PROBE UM-G20-29RTransducer, ultrasonic, diagnostic19 reports
- ULTRASONIC PROBE UM-3RTransducer, ultrasonic, diagnostic18 reports
- ULTRASONIC PROBE UM-S20-20RTransducer, ultrasonic, diagnostic18 reports
- ULTRASONIC PROBE UM-S20-17STransducer, Ultrasonic, Diagnostic18 reports
- ULTRASONIC PROBE UM-S20-17STransducer, ultrasonic, diagnostic16 reports
- ULTRASONIC PROBE UM-2RTransducer, ultrasonic, diagnostic8 reports
- ULTRASONIC PROBE UM-3RTransducer, ultrasonic, diagnostic6 reports
- ULTRASONIC PROBE UM-2RTransducer, ultrasonic, diagnostic4 reports
- ULTRASONIC PROBE UM-DP20-25REndoscopic ultrasound system, gastroenterology-urology3 reports
- ULTRASONIC PROBE UM-S20-20RTransducer, ultrasonic, diagnostic2 reports
- ULTRASONIC PROBE UM-DP20-25REndoscopic video imaging system/component, gastroenterology-urology2 reports
- ULTRASONIC PROBE UM-DG20-31REndoscopic video imaging system/component, gastroenterology-urology2 reports
- ULTRASONIC PROBE UM-BS20-26RTransducer, ultrasonic, diagnostic1 report
- ULTRASONIC PROBE UM-DP12-25REndoscopic video imaging system/component, gastroenterology-urology1 report
- ULTRASONIC PROBE RU-12M-R1Colonoscope and accessories, flexible/rigid1 report
Recent ULTRASONIC PROBE adverse event reports
The 15 most recent reports across all models, 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, 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 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 ↗MalfunctionSep 2, 2026Device Contamination with Body Fluid
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50555946 ↗MalfunctionJul 28, 2026Break
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50054818 ↗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 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 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 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 ↗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 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 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 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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