Olympus WA4KS400Recalls & reported problems
OLYMPUS Winter & Ibe GmbH · Telescope "ULTRA", 4 mm, 0° · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus WA4KS400 is a 4 mm rigid telescope used in nasopharyngoscopy to view the nose and throat. The 38 adverse event reports mostly describe the scope breaking, cracking or chipping, along with scratched surfaces and a damaged lens or tip cover glass, with no patient injuries or deaths reported. No recalls name this device.
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
- 40
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 04042761083034), received between Jan 17, 2023 and Sep 25, 2026 — classified as 40 malfunctions.
The most frequently reported specific device problem is “Break” (24 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
- Break24
- Scratched Material6
- Crack5
- Detachment of Device or Device Component2
- Defective Component1
- Degraded1
- Poor Quality Image1
Patient problems
- No Clinical Signs, Symptoms or Conditions40
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Crack
During on site inspection of Olympus Rigid Rhinoscope, it was found chipped distal end. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895659 ↗MalfunctionSep 10, 2026Break
During inspection of rigid rhinoscope, it was found distal end chipped. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50704256 ↗MalfunctionAug 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50508073 ↗MalfunctionAug 13, 2026Crack
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50240872 ↗MalfunctionMay 10, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID SCOPE EXHIBITED CHIPPPED LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25133701 ↗MalfunctionMar 11, 2026Degraded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID RHINOSCOPE HAD SCATTERED OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24571931 ↗MalfunctionFeb 10, 2026Crack
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24306171 ↗MalfunctionFeb 10, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID RHINOSCOPE EXHIBITED A DAMAGED INSERTION TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24305197 ↗MalfunctionFeb 10, 2026Break
IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE RIGID RHINOSCOPE HAD DAMAGED COVER GLASS TIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24305090 ↗MalfunctionFeb 3, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID RHINOSCOPE HAD TIP COVER GLASS DAMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24251441 ↗MalfunctionFeb 3, 2026Scratched Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID RHINOSCOPE HAD SCRATCHES ON THE EYEPIECE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24251350 ↗MalfunctionFeb 3, 2026Scratched Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID RHINOSCOPE HAD TIP COVER GLASS DAMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24251186 ↗MalfunctionJan 30, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID RHINOSCOPE HAD DAMAGE TO THE TIP COVER GLASS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24220412 ↗MalfunctionJan 13, 2026Crack
IT WAS REPORTED THAT THE RIGID RHINOSCOPE HAD A CRACKED LENS. THIS ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24054940 ↗MalfunctionDec 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE RIGID SCOPE HAD THE ADAPTER CONNECT TO THE LIGHT CABLE CAME OFF. THE ISSUE WAS FOUND DURING A SEDATION FOR A THERAPEUTIC OTOLARYNGOLOGY PROCEDURE FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23774913 ↗MalfunctionOct 16, 2025Crack; Crack
IT WAS REPORTED THAT THE RIGID SCOPE HAD A CRACKED LENS AT THE DISTAL END. THE ISSUE WAS OBSERVED DURING INSTALLATION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23319785 ↗MalfunctionSep 3, 2025Scratched Material; Scratched Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A SCRATCH ON THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22954330 ↗MalfunctionSep 3, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED BROKEN LENS IN OPTICAL SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22951473 ↗MalfunctionJul 3, 2025Break; Break
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD BROKEN LENS DURING SET UP / INSPECTION FOR USE (DURING SET UP IN ROOM / BEFORE PATIENT IN ROOM). THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22394767 ↗MalfunctionMay 19, 2025Break; Break
IT WAS REPORTED THE LENS OF THE RIGID SCOPE WAS ¿SUSPECTED TO BE BROKEN¿, FOUND DURING SET UP. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22047766 ↗MalfunctionMar 27, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED BROKEN INTERNAL LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21707280 ↗MalfunctionMar 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21698917 ↗MalfunctionMar 7, 2025Poor Quality Image; Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE HAD EXHIBITED DAMAGE TO THE INTERNAL LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21545600 ↗MalfunctionFeb 21, 2025Break; Break
IT WAS REPORTED THE SUBJECT DEVICE HAD BROKEN LENS DURING SET UP/ INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21436712 ↗MalfunctionFeb 10, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21350158 ↗
Other Nasopharyngoscope (Flexible Or Rigid) devices
- ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-10Olympus Medical Systems Corp. · Nasopharyngoscope (Flexible Or Rigid)785 reports
- NA 242268Medos International Sàrl · Nasopharyngoscope (flexible or rigid)573 reports
- EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180Olympus Medical Systems Corp. · NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)3 recalls1 death408 reports
- VIVIDEO VNL9-CPHoya Corporation · Nasopharyngoscope (Flexible Or Rigid)389 reports
- PENTAX FNL-10RP3Hoya Corporation · NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)322 reports
- SINGLE USE BIOPSY VALVE MAJ-210Olympus Medical Systems Corp. · Nasopharyngoscope (Flexible Or Rigid)1 recall221 reports
- SINGLE USE SUCTION VALVE MAJ-209Olympus Medical Systems Corp. · Nasopharyngoscope (Flexible Or Rigid)228 reports
- PENTAX FNL-7RP3Hoya Corporation · NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)227 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 16, 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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