Olympus A42091ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04042761023689), received between Jan 4, 2024 and Jul 27, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50028133 ↗
• MalfunctionMar 30, 2026Complete Blockage

  IT WAS REPORTED THAT THE INSERT HAD RUBBER STUCK INSIDE. NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727140 ↗
• MalfunctionMar 22, 2024Material Disintegration; Material Disintegration

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE WORKING INSERT, EXHIBITED SCRATCHES ON YELLOW SEAL AND DAMAGED ADHESIVE BETWEEN COMPONENTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18962051 ↗
• MalfunctionJan 4, 2024Peeled/Delaminated; Peeled/Delaminated

  THE OLYMPUS HYSTERO-RESECTOSCOPE WORKING INSERT WAS RETURNED AS PART OF THE ASSET RETURN PROCESS. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS FOUND THAT THE GLUE BETWEEN THE CHANNELS WAS BLISTERING/PEELING. THERE WAS NO PROCEDURAL OR PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18445665 ↗