Olympus WA22301SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14042761082386), received between Jan 23, 2023 and Jan 23, 2023 — classified as 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · 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.

• MalfunctionJan 23, 2023Break; Break

  IT WAS REPORTED TO OLYMPUS THAT WHEN THE (B)(4) (RESECTION ELECTRODE) WAS REMOVED FROM THE STERILIZED PACK BY THE TRANSURETHRAL RESECTION OF THE PROSTATE IN SALINE (TURIS) TECHNIQUE, THE ELECTRODES WERE DEFORMED AND COULD NOT BE ATTACHED. COMPLETED THE PROCEDURE OF SWITCHING TO THE SAME PRODUCT. NO HEALTH HAZARD TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16224913 ↗