Olympus A22257CRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14042761030448), received between Jun 10, 2019 and Jun 10, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unintended Electrical Shock” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 8, 2023Open, Classified

   Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endoscopic equipment, implants or stents. As a result, fragments can fall inside the patient and must be retrieved. (2) The second Caution refers to the risk of sparkover when getting in contact with metal parts as this can cause uncontrolled heating of the HF-resection electrode and may result in damage and breakage to the HF-resection electrode tip

   Z-2413-2023 · Root cause: Process design · FDA record ↗

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.

• MalfunctionJun 10, 2019Unintended Electrical Shock; Unintended Electrical Shock

  THE SERVICE CENTER WAS INFORMED THAT DURING UNSPECIFIED PROCEDURE, WHILE USING THE ELECTRODE THE DOCTOR FELT A SHOCK. THERE WAS NO TREATMENT REQUIRED. THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO EFFECT TO THE PATIENT.

  Patient problems: Shock

  MAUDE report 8685488 ↗