ULTRASONIC PROBE UM-S20-17S (UDI 04953170241000)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04953170241000), received between Apr 9, 2021 and Apr 13, 2026 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (7 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.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Break

  DURING THE DEVICE EVALUATION, IT WAS FOUND THAT THE TIP OF THE ULTRASONIC PROBE WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24867585 ↗
• MalfunctionApr 13, 2026Material Fragmentation; Material Twisted/Bent

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC PROBE HAD A BIG KINK ON THE PROBE¿S CABLE UNIT AND ALSO FOUND A PIECE OF THE LOCK PIN WAS CHIPPED OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24861011 ↗
• MalfunctionJun 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE ULTRASONIC PROBE EXHIBITED BLOOD INSIDE THE MINI PROBE. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY (EBUS), WHICH WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE AFTER A PROCEDURAL DELAY UNDER SEDATION (MORE THAN 30 MINUTES) TO CHANGE THE PROBE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22297935 ↗
• MalfunctionJun 12, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, AN INDENTATION AT THE TIP OF THE INSERTION PART WAS FOUND. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19523161 ↗
• MalfunctionJun 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A TEAR AT THE END OF THE MINI PROBE. THE ISSUE OCCURRED PRIOR TO AN UNSPECIFIED DIAGNOSTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19467066 ↗
• MalfunctionApr 8, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, THE ULTRASONIC PROBE HAD A GREY WIRE THAT WAS KINKED AND PINCHED REALLY BAD. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19062289 ↗
• MalfunctionMar 20, 2024Break; Break

  IT WAS REPORTED THE ULTRASONIC PROBE WAS BROKEN. THE ISSUE WAS FOUND DURING PREPARATION OF AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18943345 ↗
• MalfunctionMar 14, 2024Break; Break

  IT WAS REPORTED THAT THE ULTRASONIC PROBE BROKE OFF DURING THE PROCEDURE. NO MESSAGES WERE DISPLAYED OTHER THAN THE PROBE STARTED CURLING FAST. THE ISSUE OCCURRED DURING BRONCHOSCOPY WITH ENDOBRONCHIAL ULTRASOUND UNDER NAVIGATION, WHICH WAS COMPLETED USING THE SAME SET OF EQUIPMENT. AN XRAY WAS DONE TO CONFIRM THAT NOTHING WAS LEFT IN THE PATIENT. THERE WERE NO REPORTS OF PROCEDURE EXTENSION AND PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18907301 ↗
• MalfunctionSep 6, 2023Break; Leak/Splash; Break; Leak/Splash

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE ULTRASONIC PROBE DID NOT PRODUCE A FULL IMAGE. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. DURING EVALUATION, THE DEVICE'S INSERTION TUBE HAD CRACKS PERFORATING THE TIP AND ULTRASOUND MEDIUM HAD LEAKED OUT. THIS MEDICAL DEVICE REPORT (MDR)IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. THE CUSTOMER REPORTED THE IMAGE ISSUE WAS DETECTED DURING INSPECTION PRIOR TO PROCEDURE. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17693420 ↗
• MalfunctionJun 13, 2023Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING EXAMINATION ( UNSPECIFIED PROCEDURE) WITH A BRONCHOSCOPE, THE ULTRASOUND IMAGE WAS NOT DISPLAYED FROM THE BEGINNING OF THE EXAMINATION, AND THE IMAGE WAS NOT DISPLAYED EVEN AFTER MULTIPLE REPLACEMENTS. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE WITH NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. DEVICE RETURN EVALUATION FOUND IMAGE WAS NOT DISPLAYED, DAMAGE, LEAKAGE IN THE INSERTION TUBE WAS OBSERVED. THIS REPORT BEING SUBMITTED DUE TO THE FINDING OF DAMAGE, LEAKAGE IN INSERTION TUBE IDENTIFIED DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17115525 ↗
• MalfunctionFeb 2, 2023Break; Mechanical Problem; Break; Mechanical Problem

  CUSTOMER REPORTED WITH "TIP IS NOT ON THE PROBE". TIP FELL OFF. NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16281952 ↗
• MalfunctionMay 23, 2022Device Contamination with Body Fluid; Device Contamination with Body Fluid

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING REPROCESSING IMMEDIATELY AFTER A PROCEDURE, IT WAS OBSERVED THAT THERE WAS PRESENCE OF BLOOD INSIDE THE ULTRASOUND TIP. THERE IS NO POSSIBILITY THAT THE DEVICE WAS USED IN ANY OTHER PROCEDURE WITH THE PRESENCE OF BLOOD INSIDE THE ULTRASOUND TIP. THERE IS NO HARM TO ANY PATIENT OR PERSONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14469713 ↗
• MalfunctionNov 21, 2021Stretched; Stretched

  THE OPERATIONS MANAGER KELLEY BARLEY FURTHER REPORTED THE REPORTED EVENT OCCURRED AT THE BEGINNING OF A BRONCHOSCOPY PROCEDURE. NO DEVICE FRAGMENT FELL INSIDE THE PATIENT AS THE PROBE BROKE BEFORE IT WAS EVER USED. THE PROCEDURE COULD NOT BE COMPLETED/ THERE WAS NO DELAY AND NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12849897 ↗
• InjurySep 21, 2021Material Separation; Material Separation

  IT IS REPORTED BY THE CUSTOMER, AN UNSPECIFIED PROCEDURE WAS PERFORMED USING AN ULTRASONIC PROBE. THE PROCEDURE WENT GREAT. ONCE THE PROBE WAS REMOVED FROM THE PATIENT IT WAS TAKEN TO THE REPROCESSING ROOM, WHERE IT WAS NOTICED THAT THE RADIAL TRANSDUCER (TIP) WAS MISSING FROM THE PROBE. THE PROBE IS STRETCHED ABOUT 12 INCHES LONGER THAN THEIR NEW ONE, AND IS MUCH THINNER. THE SHEATH THAT THE TRANSDUCER SITS IN IS NOT BROKEN. AN X-RAY WAS PERFORMED ON THE PATIENT AND THE TRANSDUCER WAS NOT SEEN INSIDE THE PATIENT. THE CUSTOMER CONFIRMED THERE WAS NO HARM TO THE PATIENT. ADDITIONAL DETAILS REGARDING THE PATIENT AND EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12503527 ↗
• InjurySep 21, 2021Break; Stretched

  IT IS REPORTED BY THE CUSTOMER, AN UNSPECIFIED PROCEDURE WAS PERFORMED USING AN ULTRASONIC PROBE. THE PROCEDURE WENT GREAT. ONCE THE PROBE WAS REMOVED FROM THE PATIENT IT WAS TAKEN TO THE REPROCESSING ROOM, WHERE IT WAS NOTICED THAT THE RADIAL TRANSDUCER (TIP) WAS MISSING FROM THE PROBE. THE PROBE IS STRETCHED ABOUT 12 INCHES LONGER THAN THEIR NEW ONE, AND IS MUCH THINNER. THE SHEATH THAT THE TRANSDUCER SITS IN IS NOT BROKEN. AN X-RAY WAS PERFORMED ON THE PATIENT AND THE TRANSDUCER WAS NOT SEEN INSIDE THE PATIENT. THE CUSTOMER CONFIRMED THERE WAS NO HARM TO THE PATIENT. ADDITIONAL DETAILS REGARDING THE PATIENT AND EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12503467 ↗
• MalfunctionApr 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE SERVICE CENTER WAS INFORMED THAT A COMPONENT DETACHED FROM THE DEVICE, WHILE ATTEMPTING TO PLACE THE STOPPER ON. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11642239 ↗