Olympus WA22351CRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 14042761051719), received between Dec 16, 2019 and May 20, 2026 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DISTAL END OF THE RESECTION ELECTRODE CAME OFF. THE ISSUE WAS FOUND DURING A THERAPEUTIC CYSTECTOMY OF THE URETHRA AND WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25236135 ↗
• MalfunctionAug 11, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22771247 ↗
• MalfunctionJul 29, 2025Break; Break

  IT WAS REPORTED THAT THE HIGH FREQUENCY (HF) RESECTION ELECTRODE ROLLER BALL BROKE OFF WHILE IN USE AND WAS THEN RETRIEVED FROM THE PATIENT WITHOUT INCIDENT. THIS OCCURRED DURING THE THERAPEUTIC TRANSURETHRAL RESECTION IN SALINE (TURIS) PROCEDURE THAT WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22648143 ↗
• InjuryJan 16, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TRANSCERVICAL RESECTION (TCR) PROCEDURE, THE ROLLER OF THE SUBJECT DEVICE CAME OFF AND FELL INTO THE UTERUS. THE BROKEN PART WAS SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS THEN COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21175302 ↗
• InjuryNov 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE TIP ROLLER OF THE SUBJECT DEVICE FELL OFF. THE PROCEDURE WAS COMPLETED WITHOUT RETRIEVING THE FALLEN TIP. THERE HAVE BEEN NO REPORTS OF HEALTH PROBLEMS FROM THIS INCIDENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO FURTHER DETAILS HAVE BEEN PROVIDED AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 20623423 ↗
• InjuryDec 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, THE ELECTRODE ROLLER BALL BECOMING LOOSE DURING WHAT IS PRESUMED TO BE A UROLOGIC PROCEDURE. THE ROLLER BALL WAS NOT RECOVERED FROM THE MALE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER INFORMATION WAS PROVIDED REGARDING THE PATIENT NOR THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18378032 ↗
• MalfunctionApr 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER WHICH CONFIRMED THE REPORTED EVENT OCCURRED DURING A THERAPEUTIC TRANSURETHRAL RESECTION (TUR V) PROCEDURE. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE WITHOUT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16833600 ↗
• InjuryOct 22, 2021Break; 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, WHEN THE SURGEON INCREASED THE SETTINGS FROM 120 TO 200 COAG AND 200 CUT, TO REDUCE THE BLEEDING, FIRST THE LOOP AT THE DISTAL END OF THE HF RESECTION ELECTRODE BROKE AND FELL INTO THE PATIENT AND THEN THE ROLLER BALL AT THE DISTAL END OF AN OLYMPUS ROLLER ELECTRODE ALSO BROKE AND FELL INTO THE PATIENT. HOWEVER, NO FRAGMENTS REMAINED INSIDE THE PATIENT SINCE THEY WERE REPORTEDLY RETRIEVED. THE INTENDED PROCEDURE WAS COMPLETED USING SIMILAR DEVICES BUT THERE WAS AN EXTENSION OF THE PROCEDURE TIME OF APPROX. 45 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12679851 ↗
• MalfunctionJul 29, 2021Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT AT THE END OF A THERAPEUTIC TRANSURETHRAL RESECTION OF THE BLADDER TUMOR (TURBT) PROCEDURE, THE ROLLER PART AT THE DISTAL END OF THE HF-RESECTION ELECTRODE BROKE OFF AND FELL INTO THE PATIENT'S BODY CAVITY. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12244363 ↗
• MalfunctionDec 16, 2019Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF BLADDER TUMOUR (TUR-BT) PROCEDURE, THE ROLLER BALL AT THE DISTAL END OF THE HF RESECTION ELECTRODE BROKE OFF AND FELL INTO THE PATIENT¿S BLADDER. THE BROKEN OFF BALL WAS REPORTEDLY RETRIEVED BUT IT IS UNCLEAR WHETHER FRAGMENTS OF THE WIRE REMAINED INSIDE THE PATIENT. THE INTENDED PROCEDURE WAS THEN COMPLETED USING A SIMILAR DEVICE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9473568 ↗