Olympus WA22557CRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 14042761068342), received between Aug 7, 2018 and Dec 11, 2025 — classified as 2 injuries, 2 malfunctions.

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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Melted; Melted

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780310 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT AFTER TWENTY MINUTES INTO A TRANSURETHRAL RESECTION OF BLADDER (TURB) WHILE USING HF-RESECTION ELECTRODE, BUTTON, 24-28 FR., 12° AND 30°, STERILE, SINGLE USE, 12 PCS., ALONG WITH THE WORKING ELEMENT, THERE WAS NO RESECTION. THE DOCTOR INSTRUCTED THE NURSES TO CHECK THE SALINE SOLUTION AND IT WAS OK SO THEY ATTEMPTED AGAIN WITH SUCCESS. THERE WAS A UNEXPECTED LOUD SOUND FOLLOWED BY SMOKE. IT WAS STATED THAT THE PHYSICIAN WAS SCARED AND SWIFTLY PULLED THE INSTRUMENT FROM THE PATIENT RESULTING IN A BLADDER PERFORATION. THE PROCEDURE WAS TRANSITIONED TO AN OPEN PROCEDURE TO CLOSE THE PERFORATION. THE PATIENT WAS STATED TO BE STABLE AFTER THE OPEN SURGERY. THIS MDR REQUIRES 2 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6): HF-RESECTION ELECTRODE, BUTTON, 24-28 FR., 12° AND 30°, STERILE, SINGLE USE, 12 PCS., FOR TURIS, MODEL WA22557C. (B)(6) : WORKING ELEMENT, PASSIVE, FOR RESECTION IN SALINE, MODEL WA22367A. THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6), MODEL WA22557C.

  Patient problems: Internal Organ Perforation

  MAUDE report 18452268 ↗
• InjurySep 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  OLYMPUS WAS INFORMED THAT FOLLOWING A THERAPEUTIC PROCEDURE, THE PATIENT WAS OBSERVED TO HAVE A LABIA BURN. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME EQUIPMENT WITHOUT ISSUE. LATER THE SAME DAY, THE PATIENT CALLED THE HOSPITAL AS THE PATIENT WAS EXPERIENCING AN UNSPECIFIED PAIN. THE PATIENT WAS ADMITTED BACK TO THE HOSPITAL AND THE DOCTOR OBSERVED A LABIA BURN TO THE PATIENT. THERE WERE NO DETAILS PROVIDED REGARDING THE SEVERITY OF THE BURN AND HOW THE PATIENT WAS TREATED, HOWEVER, THE PATIENT WAS DISCHARGED ON THE SAME DAY.

  Patient problems: Burn(s)

  MAUDE report 7853507 ↗
• MalfunctionAug 7, 2018Break; Break

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED HF RESECTION PROCEDURE, THE BUTTON AT THE DISTAL END OF THE DEVICE BROKE OFF AND FELL INTO THE PATIENT¿S BLADDER. THE PHYSICIAN RETRIEVED THE BROKEN PIECE FROM THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7756684 ↗