ULTRASONIC PROBE UM-G20-29R (UDI 04953170078668)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04953170078668), received between Nov 26, 2020 and Feb 5, 2024 — classified as 2 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR: THE REPORTED EVENTS WERE NOT CAUSED BY OLYMPUS PRODUCTS.

  Patient problems: Cholangitis; Pancreatitis

  MAUDE report 18647900 ↗
• MalfunctionDec 7, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED THE IMAGE OF THE ULTRASONIC PROBE WAS NOT DISPLAYED WHEN CONNECTED. THE ISSUE OCCURRED WHEN PREPARING THE DEVICE FOR USE. A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18281017 ↗
• MalfunctionAug 23, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE ULTRASONIC PROBE'S ULTRASONIC IMAGES WERE NOT DISPLAYED. THE ISSUE WAS FOUND WHILE CHECKING THE DEVICE IN PREPARATION FOR USE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM REPORTED. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS IDENTIFIED: LEAKAGE OF ULTRASONIC MEDIUM FROM THE INSERTION TUBE/BREAKAGE OF THE INSERTION TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17602826 ↗
• MalfunctionAug 9, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED TO OLYMPUS, THAT THE ULTRASONIC PROBE ULTRASONIC IMAGES WERE NOT AVAILABLE DURING PRE USE INSPECTION. THE ISSUE WAS COMPLETED WITH A SIMILAR DEVICE. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND THAT THERE WAS A HOLE IN THE TIP SHEATH AND THE ULTRASONIC MEDIUM LEAKED. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17491253 ↗
• MalfunctionAug 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE TIP OF THE ULTRASONIC PROBE WAS CAUGHT IN THE GUIDE WIRE AND FELL OFF INTO THE PATIENT'S DUODENUM DURING A DIAGNOSTIC INTRADUCTAL ULTRASONOGRAPHY. THE PROCEDURE WAS COMPLETED WITH THE DEVICE, AND AT THE PHYSICIAN'S DISCRETION, THE TIP WAS NOT COLLECTED. THE FALLEN PIECE CAN BE EXPECTED TO BE EXPELLED FROM THE PATIENT'S BODY. THERE WERE NO REPORTS OF PATIENT INJURY OR ANY ADVERSE EVENTS. THERE IS NO EVIDENCE THAT A LIFE-THREATENING EVENT OCCURRED, THAT THE PATIENT DEVELOPED PERMANENT DAMAGE OR IMPAIRMENT, OR THAT ADDITIONAL MEDICAL/SURGICAL INTERVENTION WAS DONE TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17462323 ↗
• MalfunctionJun 30, 2023Leak/Splash; Leak/Splash

  DURING THE PROCEDURE, THE UM-G20-29R PROBE TIP BUCKLED AND CRACKED. AN ULTRASONIC MEDIUM LEAK MAY HAVE OCCURRED. REPLACED WITH ANOTHER ONE AND THE PROCEDURE WAS COMPLETED. THERE ARE NO HEALTH HAZARDS FROM THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243992 ↗
• MalfunctionJun 8, 2023Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE ULTRASOUND IMAGES WERE NOT CLEAR. THE REPORTED PROBLEM WAS FOUND DURING PREPARATION FOR AN UNSPECIFIED PROCEDURE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. THE DEVICE WAS RETURNED TO SERVICE WHERE EVALUATION FOUND THE DEVICE IMAGE WAS NOT VISIBLE AND THERE WAS A HOLE IN THE SHEATH AT THE TIP, CAUSING LEAKAGE. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTIONS FOUND AT EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17091520 ↗
• MalfunctionApr 13, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, ONLY THE BOTTOM HALF OF THE IMAGE WAS DISPLAYED WHEN USING THE ULTRASONIC PROBE. THE ISSUE WAS FOUND DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND THE INSERTION TUBE WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16730060 ↗
• MalfunctionMar 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER ORIGINALLY RETURNED HIS OLYMPUS ULTRASONIC PROBE DUE TO THE ULTRASONIC IMAGE NOT DISPLAYING DURING USE. THERE WAS NO PATIENT HARM REPORTED FROM THE ABOVE EVENT. DURING THE DEVICE EVALUATION, IT WAS DISCOVERED THAT THE INSERTION TUBE WAS BROKEN, AND LEAKING ULTRASONIC MEDIUM. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE LEAKING INSERTION TUBE FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16477639 ↗
• MalfunctionFeb 10, 2023No Display/Image; Leak/Splash; No Display/Image; Leak/Splash

  THE CUSTOMER REPORTED TO OLYMPUS, THE ULTRASONIC PROBE DID NOT PRODUCE ANY ULTRASOUND IMAGES. IT WAS ALSO REPORTED THAT THE ULTRASONIC MEDIUM AT THE TIP SEEMED TO LEAK AND ADHERED TO THE GLOVE. THERE DID NOT SEEM TO BE ANY CRUSHING HOLES IN THE EXTERNAL APPEARANCE OF THE PROBE. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16354646 ↗
• MalfunctionFeb 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING PREPARATION FOR USE AN IMAGE ABNORMALITY OF THE ULTRASONIC PROBE WAS DISCOVERED. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THE SUBJECT DEVICE WAS SENT BACK TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING THE FOLLOWING WAS FOUND: THERE IS LEAKAGE OF ULTRASONIC MEDIUM DUE TO THE PERFORATION OF THE TIP SHEATH. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (LIQUID LEAKAGE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16311189 ↗
• MalfunctionJan 30, 2023Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING THE PROCEDURE THE ULTRASOUND IMAGES WERE NOT CLEAR. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THE SUBJECT DEVICE WAS SENT BACK TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING THE FOLLOWING WAS FOUND: BREAKAGE OF THE INSERTION TUBE. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (BREAKAGE OF THE INSERTION TUBE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16265357 ↗
• MalfunctionNov 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT, DURING PREPARATION FOR USE, THE SUBJECT DEVICE DID NOT DRIVE WHEN CONNECTED TO THE DRIVE UNIT. THE SUBJECT DEVICE WAS SENT TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING, A LEAK WAS FOUND. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (LEAK). THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15882443 ↗
• MalfunctionAug 29, 2022Gel Leak; Gel Leak

  THE NURSE AT THE USER FACILITY REPORTED THAT THE ULTRASOUND IMAGES WERE NOT CLEARLY OUTPUT DURING AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO PATIENT HEALTH HAZARD REPORTED DUE TO THE EVENT. THE SUBJECT DEVICE WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. UPON INSPECTION AND TESTING, SERVICE FOUND THERE WERE AIR BUBBLES IN THE ULTRASONIC MEDIUM AND THERE WAS AN OILY WET FEELING ON THE SURFACE, INDICATING THAT THERE WAS A POSSIBILITY THAT THE ULTRASONIC LIQUID WAS LEAKING. ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15311771 ↗
• MalfunctionJun 23, 2022Fluid/Blood Leak; Fluid/Blood Leak

  OLYMPUS (OJ) WAS INFORMED THAT THE USER FACILITY ¿INSPECTED THE OPERATION OF THE ULTRASONIC PROBE, BUBBLES WERE FOUND AT THE TIP¿. THE PROBLEM WAS FOUND DURING INSPECTION BEFORE USE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. NO DEATH, INJURY OR HARM WAS REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14793618 ↗
• MalfunctionMay 25, 2022No Display/Image; No Display/Image

  OLYMPUS WAS INFORMED THAT ¿DURING PRE-USE INSPECTION, IT WAS DISCOVERED THAT THE EUS (ENDOSCOPIC ULTRASOUND) MAGE OF THE ULTRASONIC PROBE COULD NOT BE DRAWN¿ THE PROBE WAS REPLACED WITH ANOTHER PROBE AND THE PROCEDURE WAS COMPLETED. NO DEATH, INJURY OR HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14502550 ↗
• MalfunctionFeb 23, 2022Contamination; Contamination

  A USER FACILITY REPORTED TO OLYMPUS THAT AFTER STERILIZATION OF THE OLYMPUS, MODEL UM-G20-29R-3, ULTRASONIC PROBE A MATERIAL RESEMBLING AN OIL STAIN WAS FOUND ON THE PACK. THE PROBLEM, AS REPORTED TO OLYMPUS, WAS IDENTIFIED DURING PREPARATION FOR USE. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE. THERE WAS NO PATIENT INJURY, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13587936 ↗
• InjuryFeb 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE, "DIAGNOSTIC APPROACH USING ERCP-GUIDED TRANSPAPILLARY FORCEPS BIOPSY OR EUS-GUIDED FINE-NEEDLE ASPIRATION BIOPSY ACCORDING TO THE NATURE OF STRICTURE SEGMENT FOR PATIENTS WITH SUSPECTED MALIGNANT BILIARY STRICTURE" BY YUN NAH LEE, JONG HO MOON, HYUN JONG CHOI ET AL. THIS STUDY AIMED TO EVALUATE THE USEFULNESS OF A DIAGNOSTIC APPROACH USING ERCP-GUIDED TRANSPAPILLARY FORCEPS BIOPSY (TPB) OR EUS-FNAB ACCORDING TO THE CHARACTERISTICS OF SUSPECTED MBS. CONSECUTIVE PATIENTS DIAGNOSED WITH SUSPECTED MBS WITH OBSTRUCTIVE JAUNDICE AND/OR CHOLANGITIS WERE ENROLLED PROSPECTIVELY. ERCP WITH INTRADUCTAL ULTRASONOGRAPHY (IDUS) AND TPB WERE PERFORMED AS INITIAL DIAGNOSTIC PROCEDURES. BASED ON THE RESULTS OF IMAGING STUDIES AND IDUS, ALL MBS WERE CLASSIFIED AS EXTRINSIC OR INTRINSIC TYPE. IF THE MALIGNANCY WAS NOT CONFIRMED BY TPB, EUS-FNAB FOR EXTRINSIC TYPE OR SECOND TPB FOR INTRINSIC TYPE WAS PERFORMED. AMONG A TOTAL OF 178 PATIENTS, INTRINSIC AND EXTRINSIC TYPES WERE DETECTED IN 88 AND 90 PATIENTS, RESPECTIVELY. THE DIAGNOSTIC ACCURACY OF FIRST TPB WAS SIGNIFICANTLY HIGHER IN THE INTRINSIC THAN IN THE EXTRINSIC TYPE (81.8% VS. 67.8, P = 0.023

  Patient problems: Pancreatitis

  MAUDE report 13544234 ↗
• MalfunctionJan 18, 2021Break; Erratic or Intermittent Display; Break; Erratic or Intermittent Display

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE USER THAT DURING THE PROCEDURE, A LARGE PART OF THE ULTRASONIC IMAGE WAS NOT DISPLAYED, AND ONLY ABOUT 20% OF THE IMAGE WAS DISPLAYED. THE USER REPLACED THE DEVICE TO ANOTHER DEVICE AND COMPLETED THE PROCEDURE. THE DEVICE WAS USED WITH AN OLYMPUS FLEX VIDEOSCOPE TJF-260V. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT. OMSC INSPECTED THE DEVICE AND FOUND THAT THE ULTRASONIC IMAGE WAS NOISY AND THERE WAS A SCRATCH ON THE DISTAL END OF TRANSPARENT SHEATH SECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11190896 ↗
• MalfunctionNov 26, 2020Break; Break

  THE CUSTOMER NOTICED THAT OIL CAME OUT OF THE DISTAL END OF THE DEVICE AT PREPARATION FOR USE. THE CUSTOMER WAS PREPARING THE DEVICE BECAUSE THEY WERE GOING TO USE IT FOR INTRALUMINAL ULTRASONOGRAPHY (IDUS). SINCE THE PATIENT PROCEDURE DID NOT REQUIRE IDUS, THE DEVICE WAS NOT USED. CHOLEDOCHOSCOPY WAS SUCCESSFULLY COMPLETED INSTEAD. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10912764 ↗