Olympus WA22566SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 14042761083765), received between Feb 6, 2020 and Feb 24, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Detachment of Device or Device Component

  IT WAS REPORTED THE RESECTION ELECTRODE BLUE AND YELLOW COATING PROTRUDED AND THE DISTAL END FELL OFF. THE ISSUE WAS FOUND DURING A TRANSURETHRAL RESECTION IN SALINE - VAPORIZATION, THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24437891 ↗
• MalfunctionSep 25, 2024Break; Break

  IT WAS REPORTED THE HIGH FREQUENCY RESECTION ELECTRODE WAS DAMAGED. THE ISSUE WAS NOTICED WHEN IN THE PATIENT'S BLADDER DURING A TRANSURETHRAL RESECTION OF BLADDER TUMOR PROCEDURE. A SECOND BUTTON WAS USED BUT HAD THE SAME FAULT WAS SEEN. THE SURGEON CONTINUED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH THE FAULTY ELECTRODE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20303836 ↗
• MalfunctionSep 23, 2024Crack; Crack

  IT WAS REPORTED THE PLASMA OVAL BUTTON ELECTRODE HAD A CRACK/ SPLIT IN THE METAL. THE ISSUE OCCURRED DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278948 ↗
• InjuryDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL VAPORIZATION OF THE PROSTATE IN SALINE (TURISV) PROCEDURE, THE PATIENT'S LOWER ABDOMEN WAS FOUND TO BE FIRM AND A CHANGE IN VITAL SIGNS WAS OBSERVED. THIS WAS SUSPECTED TO HAVE BEEN CAUSED BY AN ACCUMULATION OF SALINE IN THE LOWER ABDOMEN CAUSED BY A PERFORATION IN THE URINARY TRACT THAT OCCURRED DURING THE TURISV PROCEDURE ALLOWING SALINE TO ENTER THE PERITONEAL CAVITY, WHICH HOWEVER HAS NOT BEEN CONFIRMED SO FAR. THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT AND THERE WAS NO REPORT OF A MALFUNCTION OF ANY OF THE OLYMPUS DEVICES USED.

  Patient problems: Perforation

  MAUDE report 13001091 ↗
• MalfunctionMar 3, 2020Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC PROSTATE ENUCLEATION PROCEDURE, THE BUTTON 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 ANOTHER HF ELECTRODE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9779553 ↗
• InjuryFeb 6, 2020Fumes or Vapors; Fumes or Vapors

  THE SERVICE CENTER WAS INFORMED THAT DURING A TRANS URETHRAL VAPORIZATION OF PROSTATE (TURP) PROCEDURE, THE ANESTHETIST WAS OVERCOME BY FUMES DURING PLASMA BUTTON USE AND COMPLAINED OF PLEURITIC PAIN FOR THREE DAYS FOLLOWING THE INCIDENT. IT WAS REPORTED THAT THE ODOR IN THE OPERATING THEATRE WAS MUCH STRONGER THAN NORMAL FOR PLASMA BUTTON USE. THE ODOR OCCURRED WITH TWO OF FACILITY¿S NEW SURGEONS. THE INTENDED PROCEDURE WAS COMPLETED WITH SAME DEVICE. THE ANESTHETIST DID NOT SEEK MEDICAL TREATMENT AND RECOVERED AT HOME.

  Patient problems: Pain

  MAUDE report 9676408 ↗