ULTRASONIC PROBE UM-S20-20R (UDI 04953170368592)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04953170368592), received between Sep 9, 2019 and Apr 6, 2026 — classified as 2 injuries, 16 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Detachment of Device or Device Component; Material Deformation

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC PROBE HAD A KINK ON PROBE'S CABLE UNIT AND THE LOCK PIN HAD A MINOR CHIP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24789219 ↗
• MalfunctionJan 30, 2026Break; Material Deformation

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE ULTRASONIC PROBE EXHIBITED A BROKEN PROBE, AND THE DEVICE HAD KINKS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221618 ↗
• MalfunctionDec 23, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS OBSERVED THAT DURING THE EVALUATION, THE ULTRASONIC PROBE EXHIBITED A BROKEN HOSE (INSERTION TUBE). THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23880464 ↗
• MalfunctionNov 3, 2025Leak/Splash; Deformation Due to Compressive Stress; Leak/Splash; Deformation Due to Compressive Stress

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC PROBE EXHIBITED A DENT IN THE SHEATH AT THE TIP AND THE ULTRASONIC MEDIUM LEAKED FROM THE PERFORATED PART. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452537 ↗
• MalfunctionNov 15, 2024Break; Break

  IT WAS OBSERVED, THAT DURING THE DEVICE EVALUATION. THE ULTRASONIC PROBE EXHIBITED DAMAGE AT THE INSERTION POINT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20693260 ↗
• MalfunctionOct 21, 2024Break; Stretched; Break; Stretched

  ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER. THE STRETCHED PART WAS LOCATED AT THE INSERTION TUBE, ABOUT 2 CM FROM THE GREY OPAQUE SECTION, OVER A LENGTH OF ABOUT 33 CM. THERE IS A GAP AROUND 10 CM BETWEEN THE PLASTIC SHEATH AND THE END OF THE PROBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20493441 ↗
• MalfunctionOct 15, 2024Stretched; Stretched

  IT WAS REPORTED THAT DURING A THERAPEUTIC RADIAL ENDOBRONCHIAL ULTRASOUND THE SHEATH OF THE ULTRASONIC PROBE WAS STRETCHED CREATING A GAP AT THE END. THE PROBE WAS REPLACED TO RESOLVE THE ISSUE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20450528 ↗
• MalfunctionOct 11, 2024Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20431977 ↗
• MalfunctionOct 11, 2024Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20428698 ↗
• MalfunctionSep 13, 2024Material Deformation; Material Deformation

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC PROBE EXHIBITED MINOR KINKS ON PORTIONS OF THE INSERTION TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20214558 ↗
• MalfunctionSep 4, 2024Stretched; Stretched

  IT WAS REPORTED THAT DURING PREPARATION FOR USE FOR A DIAGNOSTIC ULTRASOUND ENDOSCOPIC EXAMINATION PROCEDURE, THE SUBJECT DEVICE HAD ITS TRANSPARENT PART LONGER THAN USUAL. INTENDED PROCEDURE COMPLETED USING THE SAME SET OF EQUIPMENT THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20137737 ↗
• MalfunctionSep 4, 2024Stretched; Stretched

  IT WAS REPORTED THAT WHILE OPENING THE BOX, THE SUBJECT DEVICE HAD ITS TRANSPARENT PART LONGER THAN USUAL. THE INTENDED PROCEDURE WAS ULTRASOUND ENDOSCOPIC. THE SAME EQUIPMENT WAS USED TO FINISH THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20137160 ↗
• MalfunctionMar 22, 2024Break; No Display/Image; Break; No Display/Image

  IT WAS REPORTED THAT THE PROBE FELT "WEIRD" AND MADE A "SNAP" SOUND WHEN IT WAS IN THE PATIENT. IMMEDIATELY AFTERWARD, THE ULTRASOUND IMAGE WAS NO LONGER THERE; IT JUST LOOKED LIKE LINES COMING OFF THE MIDDLE CIRCLE INITIATOR. THE ISSUE OCCURRED DURING AN UNSPECIFIED DIAGNOSTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18958620 ↗
• MalfunctionJan 29, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED, THE ULTRASONIC PROBE IMAGE SHOWED A 'SNOWSTORM'. THE IMAGE WAS SUBOPTIMAL. IT¿S LIKE LOOKING THROUGH GLASS ON A SNOWY DAY. THE ISSUE WAS FOUND BEFORE THE PROCEDURE. THE UNSPECIFIED PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18597770 ↗
• InjuryOct 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED ¿RADIAL ENDOBRONCHIAL ULTRASOUND IN DIAGNOSING PERIPHERAL LUNG LESIONS IN A HIGH TUBERCULOSIS SETTING." THE AIM OF THIS STUDY WAS TO ASSESS THE DIAGNOSTIC UTILITY OF RADIAL ENDOBRONCHIAL ULTRASOUND (EBUS) WITH GUIDE SHEATH IN THE DIAGNOSIS OF PERIPHERAL LUNG LESIONS (PLLS), A HIGH TB INCIDENCE SETTING. TOTAL 120 PATIENTS WERE INCLUDED. THE FINAL DIAGNOSIS WAS MALIGNANCY IN 76 CASES AND BENIGN IN 44 CASES. 22 PATIENTS HAD A FINAL DIAGNOSIS OF PULMONARY TB. OVERALL, 58.8 % OF PULMONARY TB CASES RELIED ON HISTOLOGY TO MAKE AN EARLY DIAGNOSIS. THIS STUDY CONCLUDED THAT RADIAL EBUS GUIDED BRONCHOSOPY WAS USEFUL IN INVESTIGATING PLLS IN A HIGH TB INCIDENCE SETTING. THE DATA ALSO SUGGESTS THAT RADIAL EBUS WAS A MORE RAPID DIAGNOSIS TECHNIQUE FOR TUBERCULOUS LESIONS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: BLEEDING [MALIGNANT] - 5 PATIENTS. BLEEDING [BENIGN] - 2 PATIENTS. PNEUMOTHORAX - 1 PATIENT. THIS LITERATURE ARTICLE REQUIRES 2 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6) :BF-1T260. (B)(6) :UM-S20-20R. THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6). THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 15680295 ↗
• InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "TREATMENT RESULTS OF ENDOSCOPIC MUCOSAL RESECTION WITH A LIGATION DEVICE FOR DUODENAL NEUROENDOCRINE TUMORS". LITERATURE SUMMARY: THIS STUDY EXAMINED THE TREATMENT RESULTS OF ENDOSCOPIC MUCOSAL RESECTION WITH A LIGATION DEVICE (EMR-L) FOR THE REMOVAL OF DUODENAL NETS LOCATED IN THE SUBMUCOSAL LAYER WITHOUT METASTASIS. EMR-L CAN BE PERFORMED WITH LESS TECHNICAL SKILL, AND THE LIGATION DEVICE REDUCES THE RATE OF POSITIVE VERTICAL MARGIN. THE EN BLOC RESECTION RATE AND ENDOSCOPIC COMPLETE RESECTION RATE WERE BOTH 100%. COMPLETE RESECTION WAS ACHIEVED PATHOLOGICALLY IN 7 LESIONS (70.0%). THE VERTICAL MARGINS WERE NEGATIVE IN ALL CASES. LYMPHATIC VESSEL INVASION WAS OBSERVED IN THREE PATIENTS, ALL OF WHOM UNDERWENT ADDITIONAL SURGERY WITH LYMPH NODE DISSECTION (ONE OF THEM ALSO EXHIBITED BLOOD VESSEL INVASION AND A POSITIVE HORIZONTAL MARGIN). NO EVIDENCE OF RESIDUAL TUMORS OR LYMPH NODE METASTASIS WAS OBSERVED IN ANY OF THE PATIENTS. NO RECURRENCE WAS OBSERVED IN ANY OF THE 10 PATIENTS (MEAN FOLLOW-UP PERIOD: 18.6 MONTHS). ONE PATIENT (10.0%) EXPERIENCED INTRAOPERATIVE BLEEDING. PERFORATION OCCURRED IN 1 PATIENT (10.0%), BUT THE CONDITI

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 14346420 ↗
• MalfunctionMar 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FROM A USER FACILITY WITH NO ALLEGED COMPLAINT. DURING RECEIPT INSPECTION, IT WAS FOUND THAT THE WATERPROOF CAP WAS MISSING AND COULD NOT BE WASHED. UPON FURTHER INSPECTION AND TESTING OF THE DEVICE, IT WAS OBSERVED THAT THERE WAS A LACK OF ULTRASOUND MEDIUM WITHIN THE DEVICE. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (LACK OF ULTRASOUND MEDIUM). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13759507 ↗
• MalfunctionSep 9, 2019Material Separation; Material Separation

  DURING A BRONCHOSCOPY, THE DISTAL END OF THE DEVICE FELL OFF INTO THE PATIENT'S CAVITY. THE USER RETRIEVED THE DISTAL END FROM THE PATIENT'S CAVITY. THE USER REPLACED THE SUBJECT DEVICE WITH A SIMILAR DEVICE AND COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF THE PATIENT¿S INJURY REGARDING THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8973952 ↗