Olympus WA2T400ARecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04042761077491), received between Dec 27, 2022 and Mar 30, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Material Fragmentation

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE PRESENTED CHIPPED LENS IN THE OPTICAL SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24726619 ↗
• MalfunctionDec 29, 2025Break; Break

  IT WAS REPORTED THAT THE RIGID ENDOSCOPE TELESCOPE HAD BROKEN LENS DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23908532 ↗
• MalfunctionApr 17, 2025Break; Break

  IT WAS REPORTED THE SUBJECT DEVICE HAD BROKEN. THIS ISSUE OCCURRED DURING SET UP. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21854858 ↗
• MalfunctionFeb 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GUIDE PIN CAME OFF FROM THE SUBJECT DEVICE. THE ISSUE OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21470158 ↗
• MalfunctionJul 18, 2024Break; Break

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE TELESCOPE EXHIBITED HAD A LOCKING PIN WAS FOUND BROKEN. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19772618 ↗
• MalfunctionJan 2, 2024Defective Component; Defective Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE TELESCOPE "OES ELITE", 4 MM, 0°, HD, AUTOCLAVABLE LENS WAS MISSING. THE EVENT OCCURRED DURING REPROCESSING. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18424855 ↗
• MalfunctionNov 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE TELESCOPE "OES ELITE", 4 MM, 0°, HD, AUTOCLAVABLE HAD THE BLACK EYE PIECE FALL OFF. THE EVENT OCCURRED DURING PREPARATION FOR USE IN A THERAPEUTIC CYSTOSCOPY PROCEDURE. THERE WAS NO DELAY, AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18130058 ↗
• MalfunctionMar 22, 2023Break; Crack; Break; Crack

  COMPANY REPRESENTATIVE REPORTED BROKEN LIGHT POST. THE ISSUE FOUND DURING AN UNKNOWN EVENT. NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16595773 ↗
• MalfunctionDec 27, 2022Crack; Crack

  OLYMPUS WAS INFORMED THAT THE CUSTOMER ¿OES ELITE¿ HIGH-DEFINITION AUTOCLAVABLE TELESCOPE WAS RETURNED TO THE OLYMPUS REPAIR CENTER FOR A REPORTED ¿BLURRY LENS¿. THE CUSTOMER REPORTED DEFECT WAS FOUND AT REPROCESSING. NO DEATH INJURY OR INFECTION AND NO PERSON OR OTHER WAS AFFECTED HAS BEEN REPORTED TO OLYMPUS. HOWEVER, DURING THE REPAIR INSPECTION, OLYMPUS FOUND THE EYEPIECE FUNNEL IS CRACKED. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE BROKEN EYE PIECE COMPONENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16053115 ↗