Olympus WA4KA470Recalls & reported problems
OLYMPUS Winter & Ibe GmbH · Telescope "ULTRA", 4 mm, 70°, with trocar tube connector · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04042761083027), received between Jun 5, 2023 and Mar 24, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Crack1
- Detachment of Device or Device Component1
- Material Integrity Problem1
- Noise, Audible1
- Thermal Decomposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 24, 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 24679881 ↗MalfunctionApr 24, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE RIGID ARTHROSCOPE'S EYEPIECE FUNNEL HAD A MINOR BURN. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19174848 ↗MalfunctionFeb 28, 2024Crack; Material Integrity Problem; Noise, Audible; Crack; Material Integrity Problem; Noise, Audible
IT WAS REPORTED, THE RIGID RHINOSCOPE HAD A MECHANICAL DAMAGE AND NOISE. THE SOUND BLACK EYE PIECE WAS CRACKED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18797121 ↗MalfunctionDec 31, 2023Break; Break
THE CUSTOMER REPORTED TO OLYMPUS, THE TELESCOPE ULTRA¿, 4 MM, 70°, WITH TROCAR TUBE CONNECTOR, HAD LENS DAMAGE. THE ISSUE WAS FOUND DURING THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18423055 ↗MalfunctionJun 5, 2023Break; Break
THE BIOMEDICAL ENGINEER AT THE USER FACILITY REPORTED THE LENS APPEARS CRACKED WHEN LOOKING THROUGH THE ¿ULTRA¿ RIGID TELESCOPE. THE CUSTOMER REPORTED PROBLEM WAS FOUND DURING REPROCESSING. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17065526 ↗
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- FMS VUE II 284004Medos International Sàrl · Arthroscope562 reports
- VAPR COOLPULSE 228146Depuy Mitek, LLC · ARTHROSCOPE474 reports
- FMS DUO 284580Depuy Mitek, LLC · ARTHROSCOPE458 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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