Olympus A20971ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04042761020367), received between Oct 11, 2019 and Oct 11, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2019Material Fragmentation; Material Fragmentation

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED THERAPEUTIC CYSTOSCOPY PROCEDURE, THE SURGEON NOTICED FOREIGN PARTICLES IN THE PATIENT¿S BLADDER, WHICH HAD COME OFF THE CYSTOSCOPE DURING THE PROCEDURE. HOWEVER, NO FRAGMENT REMAINED INSIDE THE PATIENT SINCE THE PARTICLES WERE REPORTEDLY RETRIEVED. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9178634 ↗