Olympus WA47505SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14042761085035), received between Dec 13, 2023 and Nov 13, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A "TCR" CASE, THE LOOP OF THE DEVICE BROKE AND FELL OFF INSIDE THE BODY. THE FALLEN PIECES WERE COLLECTED BY SUCTION. THE PROCEDURE WAS COMPLETED BY REPLACING IT WITH A SIMILAR DEVICE WITHOUT ANY DELAY OR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674396 ↗
• InjuryDec 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER THAT THE ELECTRODE FELL INTO THE PATIENT'S BODY DURING A GYNECOLOGICAL TRANSCERVICAL RESECTOSCOPE (TCR) PROCEDURE. NO HEALTH HAZARD REPORTED. ADDITIONAL INFORMATION FOR PATIENT'S CURRENT CONDITION, PROCEDURAL DETAILS AND OUTCOME OF THE PROCEDURE WERE REQUESTED BUT NOT AVAILABLE AT THE TIME OF THE REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18320675 ↗