Olympus A22255CRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 14042761036839), received between May 30, 2019 and Mar 19, 2024 — classified as 1 injury, 2 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.

• InjuryMar 19, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THE TIP OF THE HIGH FREQUENCY RESECTION ELECTRODE BROKE WHILE INSIDE THE PATIENT DURING A HYSTEROSCOPY/DILATION AND CURETTAGE (D&C) PROCEDURE. THE BROKEN PORTION WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THE DEVICE WAS DISCARDED. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18935494 ↗
• MalfunctionMay 6, 2022Break; Sparking

  SHORTLY AFTER THE PROCEDURE IS STARTED, A LOUD POP IS HEARD AND IMMEDIATELY REALIZED THAT MONOPOLAR CORD SPARKED AND BROKEN OFF WHERE IT ATTACHES TO ESU (ELECTRO-SURGICAL UNIT) MACHINE.

  Patient problems: Insufficient Information

  MAUDE report 14308730 ↗
• MalfunctionMay 30, 2019Break; Break

  THE SERVICE CENTER WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE DOCTOR OBSERVED THAT THE STERILE DISPOSABLE ELECTRODE NEEDLE BROKE OFF AND FELL INTO THE PATIENT¿S BLADDER. THE DOCTOR WAS ABLE RETRIEVE THE METAL DEVICE FRAGMENT. THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8654958 ↗