Olympus A22081ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04042761021159), received between Jun 14, 2024 and Jun 14, 2024 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 14, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE INCIDENT OCCURRED DURING A BLADDER RESECTION USING BIPOLAR ENERGY. THE BLADDER PERFORATION OCCURRED WHEN THE SURGEON APPROACHED THE PATIENT¿S OBTURATOR NERVE. THE PATIENT WAS NOT INJURED BY ELECTRIC CURRENT AND/OR SHOCK. THE GENERATOR DID NOT DISPLAY AN ERROR MESSAGE. THE GENERATOR WAS PROGRAMMED TO A ¿CLASSIC¿ BIPOLAR SETTING RECOMMENDED BY OLYMPUS. DUE TO THE BLADDER PERFORATION, AN EMERGENCY LAPAROTOMY WAS PERFORMED. THIS RESULTED IN A 1-HOUR PROCEDURAL DELAY. THE SURGEON REPORTED THE INCIDENT TO THE HOSPITAL¿S BIOMEDICAL TEAM.

  Patient problems: Internal Organ Perforation

  MAUDE report 19538767 ↗