Olympus WA4KS430Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04042761083041), received between Jan 10, 2023 and Mar 6, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24537235 ↗
• MalfunctionFeb 26, 2026Unstable

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID SCOPE EXHIBITED LOOSE COLOR RING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24460463 ↗
• MalfunctionApr 27, 2023Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE TELESCOPE "ULTRA", 4 MM, 30° HAS BROKEN OPTIC. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16826311 ↗
• MalfunctionJan 10, 2023Fracture; Fracture

  THE OLYMPUS SALES REPRESENTATIVE REPORTED, THE CUSTOMER ULTRA AUTOCLAVABLE TELESCOPE HAS A REPORTED OUT OF BOX DEFECT ¿LENS IS CRACKED UPON OPENING PACKAGE¿. NO PATIENT OR PROCEDURE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16132787 ↗