Olympus WA22305SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 14042761082393), received between Oct 2, 2020 and May 11, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Break

  IT WAS REPORTED THE HF-RESECTION ELECTRODE LOOP WAS POORLY BENT. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25136138 ↗
• MalfunctionMay 1, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT, ¿DURING THE TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE, THE TIP OF THE LOOP ELECTRODE BROKE AND FELL OUT INTO THE BODY.¿ THE TIP THAT FELL OFF HAS ALREADY BEEN RECOVERED FROM THE PATIENT, AND ANOTHER ELECTRODE WAS USED TO COMPLETE THE INTENDED PROCEDURE, WITH NO IMPACT ON THE PATIENT OR HEALTH HAZARD. IT WAS REPORTED THE SURGEON MAY HAVE USED THE ELECTRODE WHILE TWISTING IT SLIGHTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16850689 ↗
• MalfunctionOct 2, 2020Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF A BLADDER TUMOR (TURBT) PROCEDURE, THE LOOP WIRE AT THE DISTAL END OF THE HF RESECTION ELECTRODE BROKE AND FRAGMENTS MAY HAVE FALLEN INTO THE PATIENT¿S BLADDER. THIS HAPPENED WHEN THE ESG-400 GENERATOR WAS UNPLUGGED, AND RESTARTED AFTER IT HAD PERFORMED AN AUTOMATIC RESTART. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE, AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10618760 ↗