Olympus WA96205ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04042761070072), received between Mar 8, 2023 and May 18, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Thermal Decomposition of Device

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID RHINOSCOPE ADHESIVE WAS BURNED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25204392 ↗
• MalfunctionMar 18, 2026Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID RHINOSCOPE HAD DETACHED DISTAL TERMINAL LENS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24625328 ↗
• MalfunctionAug 11, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A BURNT LIGHT GUIDE CONNECTING SECTION AND LIGHT GUIDE CONNECTOR. THE EVENT OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22772492 ↗
• MalfunctionJun 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING REPROCESSING OF THE SUBJECT DEVICE, THE RIDE GUIDE CONNECTING SECTION BASE CAME OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22151157 ↗
• MalfunctionJan 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, THE TELESCOPE HAD A BLOTCHY IMAGE DUE TO DEPOSITS ON THE COVER GLASS. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: LIGHT GUIDE POST DETACHED FROM BASE. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18535232 ↗
• MalfunctionSep 1, 2023Break; Break

  THE CUSTOMER ORIGINALLY RETURNED HIS OLYMPUS AUTOCLAVABLE TELESCOPE DUE TO THE UNIT PRODUCING A CLOUDY IMAGE. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED BUT WERE UNKNOWN BY THE INITIAL REPORTER. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT. DURING THE DEVICE EVALUATION, IT WAS DISCOVERED THAT THE DEVICE¿S LENS HAD BEEN DAMAGED. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE DAMAGED LENS CONFIRMED DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17670178 ↗
• MalfunctionMar 8, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE TELESCOPE, 4 MM, 70°, CONNECTOR FOR LIGHT GUIDE ON BOTTOM, AUTOCLAVABLE HAD A BROKEN LIGHT GUIDE POST. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THE INTENDED PROCEDURE WAS ENDOSCOPIC SINUS SURGERY. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16503995 ↗