Olympus WA2UR14ARecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04042761086363), received between Oct 19, 2021 and May 23, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Break” (12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2026Break

  THE RIGID URETEROSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF TIP WAS BENT. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, COVER GLASS OF THE TIP IS FRAGMENTED WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25263699 ↗
• MalfunctionMay 21, 2026Poor Quality Image; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THE RIGID URETEROSCOPE EXHIBITED OPTICAL FIBER EXPOSED TO CHEMICALS. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241555 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT THE RIGID UTEROSCOPE EXHIBITED DAMAGED DISTAL END, FOUND DURING UNPACKING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24734002 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID URETEROSCOPE EXHIBITED A BROKEN COVER GLASS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273683 ↗
• MalfunctionDec 8, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743922 ↗
• MalfunctionJul 2, 2025Break; Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A BROKEN STOPCOCK/IRRIGATION PORT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22386714 ↗
• MalfunctionJun 18, 2025Material Frayed; Melted; Material Deformation; Material Frayed; Melted; Material Deformation

  IT WAS REPORTED THE SUBJECT DEVICE HAD CRUSHING/ BURNING OF THE TIP IN THE AREA OF THE FIBER OPTIC OUTLET AND METAL EDGES PROTRUDING BEYOND THE OUTLINE OF THE OPTICS. THE ISSUE OCCURRED DURING SERVICE / MAINTENANCE (NOT IN A CLINICAL SETTING). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22283116 ↗
• MalfunctionJun 2, 2025Break; Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED DISTAL END TIP LENS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22124826 ↗
• MalfunctionApr 17, 2025Break; Break

  IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE STOPCOCK ON THE OUTER TUBE OF THE SUBJECT DEVICE WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21854610 ↗
• MalfunctionNov 29, 2024Poor Quality Image; Poor Quality Image

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20810965 ↗
• MalfunctionOct 8, 2024Break; Break

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE RIGID URETEROSCOPE'S HANDLE WAS BROKEN. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20396204 ↗
• MalfunctionOct 3, 2024Break; Break

  IT WAS REPORTED THE RIGID URETEROSCOPE GRIP UNIT WAS BROKEN. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20365083 ↗
• MalfunctionSep 20, 2024Break; Break

  IT WAS REPORTED THAT THE URETEROSCOPE HAD A CHIPPED TIP. THE INTENDED PROCEDURE WAS CANCELED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20267501 ↗
• MalfunctionMay 24, 2024Break; Component Missing; Break; Component Missing

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE RIGID OPTICAL URETEROSCOPE STOPCOCK WAS FOUND BROKEN AND MISSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19396635 ↗
• MalfunctionMar 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THAT THE URETEROSCOPE WAS NOT WORKING WITH THE DISTAL END LENS LOOSE AND DETACHED. THE ISSUE WAS FOUND DURING THE THERAPEUTIC STENT REMOVAL PROCEDURE THAT WAS COMPLETED BY A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18918218 ↗
• MalfunctionNov 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18125763 ↗
• MalfunctionSep 7, 2023Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE URETEROSCOPE 7.3/10.4 FR. X 430 MM, 5°, ANGLED OCULAR, 6.4 FR. CHANNEL OPTICS FOGGED. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE DEVICE WAS EVALUATED, AND IT WAS FOUND THAT THE PLAN GLASS AT DISTAL END WAS DAMAGED. THIS MDR (MEDICAL DEVICE REPORT) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17697697 ↗
• MalfunctionJun 12, 2023Material Twisted/Bent; Material Twisted/Bent

  A USER FACILITY RETURNED THE OLYMPUS ASSET TO THE OLYMPUS SERVICE CENTER. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE TIP OF THE DEVICE WAS BENT AND SHARP. THIS REPORT IS BEING SUBMITTED FOR THE EVENT FOUND DURING EVALUATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17114132 ↗
• MalfunctionJun 6, 2023Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, THAT THE TIP BROKE OFF OF THE URETEROSCOPE. THE ISSUE WAS FOUND DURING A THERAPEUTIC URETEROSCOPY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR NON-OLYMPUS URETEROSCOPE. NO DELAY WAS REPORTED. THERE WERE NO REPORTS OF PATIENT HARM. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17074693 ↗
• MalfunctionMar 22, 2023Break; Break

  THE CUSTOMER ANGLED OCULAR RIGID URETEROSCOPE WAS RETURNED TO OLYMPUS FOR REPAIR OF A REPORTED ¿CLOUDY VISION¿. THE CUSTOMER REPORTED EVENT WAS FOUND AT AN UNSPECIFIED EVENT. UPON INSPECTING AND TESTING, OLYMPUS IDENTIFIED THE STOPCOCK VALVE BROKE OFF THE MAIN BODY OF THE SCOPE. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED TO OLYMPUS. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE BROKEN OFF STOPCOCK THAT WAS FOUND DURING THE REPAIR INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16595315 ↗
• MalfunctionOct 19, 2021Material Fragmentation; Mechanical Problem; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC LASER LITHOTRIPSY PROCEDURE, THE COVER GLASS OF THE URETEROSCOPE DETACHED AND FELL INTO THE PATIENT. HOWEVER, NO FRAGMENT REMAINED INSIDE THE PATIENT SINCE IT WAS REPORTEDLY RETRIEVED. NO FURTHER INFORMATION WAS PROVIDED, BUT THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12655575 ↗