Olympus WA22305DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14042761051672), received between Sep 14, 2018 and Nov 18, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2025Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THE ELECTRODE WAS BENT, UPON RECEIPT OF THE RESECTION ELECTRODE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23586883 ↗
• MalfunctionSep 14, 2018Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE LOOP WIRE AT THE DISTAL END OF THE HF RESECTION ELECTRODE BROKE OFF AND FELL INSIDE THE PATIENT. HOWEVER, NO FRAGMENT REMAINED INSIDE THE PATIENT SINCE IT WAS REPORTEDLY RETRIEVED. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME SET OF EQUIPMENT AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7876061 ↗