Olympus A22000ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04042761020831), received between Sep 14, 2023 and Apr 8, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K897003); they may or may not involve this specific model.

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.

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.

• MalfunctionApr 8, 2026Material Fragmentation

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE PRESENTED CHIPPED LENS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24814572 ↗
• MalfunctionDec 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RIGID SCOPE HAD LIGHT POST ADAPTER LOOSE. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871805 ↗
• MalfunctionFeb 25, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21462517 ↗
• MalfunctionDec 4, 2024Break; Break

  IT WAS REPORTED "THE LENS ARE BROKEN" . "CAN'T SEE THROUGH THE SCOPE" .THE ISSUE WAS FOUND AT INSPECTION FOR USE BEFORE SEDATION. THERE WAS NO PATIENT OUTCOME OR CONSEQUENCES, NO HARM OR INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20849425 ↗
• MalfunctionJun 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE TELESCOPE EXHIBITED REMOVED EYEPIECE RING PARTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19600256 ↗
• MalfunctionOct 15, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE TELESCOPE TIP WAS INSPECTED BEFORE USER AND WAS FOUND TO BE CHIPPED AND CUT. THE ISSUE WAS FOUND DURING REPROCESSING AND THE INTENDED PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17936924 ↗
• MalfunctionSep 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT HIS OLYMPUS TELESCOPE HAD COMPONENT PIECE BROKEN OFF DURING DEVICE REPROCESSING. THIS EVENT HAD NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744076 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K897003. One submission often covers many models, so check the product and lot details in each record.

• Z-2029-2024 · Apr 18, 2024 · Open, Classified
  OES 4000 Hysteroscope, Model/Catalog Number: A4674A