Olympus WA52006ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Telescope, 10 mm, 45°, 460 mm, quick lock, autoclavable · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04042761052726), received between Dec 15, 2022 and Jan 7, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component2
- Break1
- Unstable1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2026Unstable; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID SCOPE EXHIBITED MISSING INNER/OUTER LIGHT GUIDE ADAPTER, AND A CHIPPED AND LOOSE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23989260 ↗MalfunctionDec 29, 2022Break; Break
OLYMPUS WAS INFORMED BY STERILE PROCESSING MANAGER AT THE USER FACILITY THAT THE CUSTOMER QUICK LOCK AUTOCLAVABLE TELESCOPE HAS A BROKEN OR LOOSE LENS DEFECT, ¿LENS MISALIGNED¿. THE REPORTED DEFECT WAS FOUND AT REPROCESSING. NO DEATH INJURY OR INFECTION AND NO PERSON OR OTHER WAS AFFECTED HAS BEEN REPORTED TO OLYMPUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16069149 ↗MalfunctionDec 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THE IMAGE FROM THE SUBJECT DEVICE WAS FOGGY WHEN ENTERING THE PATIENT DURING A LAPAROSCOPIC SLEEVE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE AND THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT. THE SUBJECT DEVICE WAS SENT TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. DURING INSPECTION AND TESTING, SERVICE FOUND THE OPTICAL SYSTEM HAD SUNK DOWN. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (SUNK DOWN OPTICAL SYSTEM).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15987284 ↗
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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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