Olympus WA47507SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 14042761085073), received between Oct 29, 2018 and Mar 4, 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.

• MalfunctionMar 4, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TCR, THERAPEUTIC PROCEDURE THE PLASMA LOOP FELL INTO THE PATIENT'S UTERUS. THE FALLEN DEVICE FLOWED OUT OF THE BODY WITH THE IRRIGATION FLUID AND HAS BEEN RETRIEVED AND NO ADDITIONAL DEVICE WAS USED. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE WITH A DELAY OF LESS THAN 30 MINUTES WITHOUT ANY REPORTS OF HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507450 ↗
• MalfunctionAug 22, 2025Break; Break

  IT WAS REPORTED THE SUBJECT DEVICE LOOP WAS BROKEN DURING A THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22871905 ↗
• MalfunctionOct 29, 2018Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSCERVICAL RESECTION OF THE ENDOMETRIUM IN SALINE (TCRIS) PROCEDURE, THE LOOP WIRE AT THE DISTAL END OF THE HF RESECTION ELECTRODE BROKE OFF AND FELL INSIDE THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8013627 ↗