Olympus WA4KS470Recalls & reported problems
OLYMPUS Winter & Ibe GmbH · Telescope "ULTRA", 4 mm, 70° · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04042761083089), received between Jan 4, 2023 and Sep 24, 2024 — classified as 4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Crack1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2024Material Deformation; Material Deformation
IT WAS REPORTED THE TELESCOPE HAD DAMAGE TO THE LIGHT GUIDE CONNECTOR. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20292875 ↗MalfunctionJan 30, 2024Break; Break
IT WAS REPORTED, THE RIGID RHINOSCOPE'S LIGHT SOURCE CONNECTION WAS DISCONNECTED. IT IS UNKNOWN WHEN THIS ISSUE WAS FOUND BUT THE PROCEDURE INVOLVED WAS THERAPEUTIC AND WAS ABLE TO BE COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18605747 ↗MalfunctionMay 5, 2023Break; Break
THE CUSTOMER REPORTED TO OLYMPUS, THE TELESCOPE "ULTRA", 4 MM, 70° HAD A DAMAGED LIGHT GUIDE CONNECTOR. THE INTENDED PROCEDURE WAS AN UNKNOWN THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16882661 ↗MalfunctionJan 4, 2023Crack; Crack
OLYMPUS (OSH) FIELD SERVICE ENGINEER WAS INFORMED BY THE CUSTOMER THAT THE OLYMPUS LOANER ULTRA AUTOCLAVABLE TELESCOPE HAS AN IMAGE PROBLEM, THERE IS A SHADOW IN THE LOWER RIGHT CORNER OF THE SURROUNDING AREA OF THE IMAGE. THE REPORTED PROBLEM WAS FOUND DURING MAINTENANCE. NO DEATH, INJURY OR HARM WAS REPORTED TO OLYMPUS. THE REFERENCED TELESCOPE WAS RETURNED TO THE OLYMPUS REPAIR CENTER AND THE INSPECTION IDENTIFIED A CRACKED LENS INSIDE THE OPTICAL SYSTEM. THIS REPORT IS BEING SUBMITTED TO CAPTURE CRACKED LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16099262 ↗
Other Nasopharyngoscope (Flexible Or Rigid) devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.