Olympus A22021ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04042761020916), received between Jun 14, 2024 and Jun 26, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2026Fracture

  THE CUSTOMER REPORTED A BROKEN TIP DURING AN UNSPECIFIED PROCEDURE INVOLVING AN OLYMPUS OUTER SHEATH. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25634606 ↗
• MalfunctionSep 17, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ENDOSCOPE SHEATH WAS DAMAGED IN SUCH A WAY IT COULD LEAD TO TRAUMA TO URETHRA RESULTING IN STRICTURES. THE ISSUE WAS FOUND DURING A DEMONSTRATION. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20241664 ↗
• InjuryJun 14, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WAS A BLADDER PERFORATION. THE PHYSICIAN FELT AS IF IT WAS DUE TO AN ELECTRICAL PROBLEM WITH THE RESECTOSCOPE. THE PATIENT HAD TO UNDERGO A LAPAROTOMY DUE TO THE PERFORATION. ADDITIONAL INFORMATION WAS REQUESTED MULTIPLE TIMES, BUT NOT RECEIVED.

  Patient problems: Internal Organ Perforation

  MAUDE report 19538647 ↗