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Olympus WA4KA430Recalls & reported problems

OLYMPUS Winter & Ibe GmbH · Telescope "ULTRA", 4 mm, 30°, with trocar tube connector · Class 2

Quick summary

This Olympus WA4KA430 is a 4 mm rigid arthroscope used to look inside joints. The 72 reports mostly describe the scope breaking or cracking, often chipping the lens or damaging the tip, and these were found during device evaluation with no patient involvement. There are no deaths and no injuries. No recalls name this device, and reports in the past 12 months (23) are higher than the 13 in the prior12 months.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
72
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 04042761083010), received between Dec 28, 2022 and May 14, 2026 — classified as 72 malfunctions.

The most frequently reported specific device problem is “Break” (43 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.

Reports received per month

Nov 2023: 4 reportsDec 2023: 1 reportsJan 2024: 4 reportsFeb 2024: 0 reportsMar 2024: 2 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 2 reportsJul 2024: 1 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 5 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 2 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 2 reportsJun 2025: 3 reportsJul 2025: 2 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 1 reportsNov 2025: 2 reportsDec 2025: 2 reportsJan 2026: 4 reportsFeb 2026: 3 reportsMar 2026: 5 reportsApr 2026: 5 reportsMay 2026: 2 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520265
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break43
  • Crack9
  • Detachment of Device or Device Component4
  • Melted3
  • Component Missing2
  • Material Deformation2
  • Material Fragmentation2
  • Scratched Material2

Patient problems

  • No Clinical Signs, Symptoms or Conditions71
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 14, 2026Break

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ARTHROSCOPE HAD CHIPPED OBJECTIVE COVER GLASS. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25174604 ↗
  • MalfunctionMay 8, 2026Break

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ARTHROSCOPE EXHIBITED CHIPPED LENS. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25123057 ↗
  • MalfunctionApr 9, 2026Detachment of Device or Device Component

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

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24832003 ↗
  • MalfunctionApr 9, 2026Crack; Melted

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ARTHROSCOPE HAD A MELTED DISTAL END, DAMAGE TO ENTIRE PLATED DISTAL END, AND DAMAGE TO LIGHT GUIDE (LG) SECTION DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24830863 ↗
  • MalfunctionApr 9, 2026Material Fragmentation

    IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE RIGID ARTHROSCOPE HAD CHIPPED LENS IN OPTICAL SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24830723 ↗
  • MalfunctionApr 8, 2026Crack

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ARTHROSCOPE HAD A CHIPPED DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24821632 ↗
  • MalfunctionApr 1, 2026Material Split, Cut or Torn

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ARTHROSCOPE HAD CHIPPED LENS. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24753531 ↗
  • MalfunctionMar 25, 2026Material Separation

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ARTHROSCOPE EXHIBITED CHIPPED LENS. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24691322 ↗
  • MalfunctionMar 25, 2026Detachment of Device or Device Component

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ARTHROSCOPE EXHIBITED CHIPPED LENS THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24685419 ↗
  • MalfunctionMar 23, 2026Detachment of Device or Device Component

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ARTHROSCOPE EXHIBITED CHIPPED LENS AND MENISCUS OUT OF PLACE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24660342 ↗
  • MalfunctionMar 9, 2026Peeled/Delaminated

    IT WAS REPORTED THAT THE RIGID ARTHROSCOPE HAD A CHIPPED END NEAR THE LENS. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24546798 ↗
  • MalfunctionMar 4, 2026Material Fragmentation

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

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24506903 ↗
  • MalfunctionFeb 3, 2026Scratched Material

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24248841 ↗
  • MalfunctionFeb 2, 2026Break

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ARTHROSCOPE HAD A BROKEN OPTICAL LENS. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24241831 ↗
  • MalfunctionFeb 2, 2026Scratched Material

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24234089 ↗
  • MalfunctionJan 30, 2026Break

    IT WAS OBSERVED DURING DEVICE EVALUATION; THE RIGID ARTHROSCOPE HAD BROKEN OPTICAL FIBER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24225733 ↗
  • MalfunctionJan 23, 2026Degraded

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24160941 ↗
  • MalfunctionJan 16, 2026Crack

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24093113 ↗
  • MalfunctionJan 6, 2026Break

    IT WAS REPORTED THE RIGID ARTHROSCOPE WAS BROKEN AT THE DISTAL END DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23978400 ↗
  • MalfunctionDec 18, 2025Break; Break

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ARTHROSCOPE EXHIBITED BREAKAGE FIBER BY DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23840441 ↗
  • MalfunctionDec 12, 2025Crack; Crack

    IT WAS REPORTED THAT THE RIGID ARTHROSCOPE EXHIBITED CRACKED LENS. THE EVENT OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23787333 ↗
  • MalfunctionNov 21, 2025Break; Break

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23617207 ↗
  • MalfunctionNov 20, 2025Overheating of Device; Overheating of Device

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ARTHROSCOPE EXHIBITED MELTED LIGHT GUIDE FIBERS AT DISTAL END DUE TO OVERHEATING. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23608226 ↗
  • MalfunctionOct 16, 2025Break; Break

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23317601 ↗
  • MalfunctionSep 10, 2025Break; Break

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23015650 ↗

Other Arthroscope devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.