Olympus A22207CRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14042761036747), received between Aug 2, 2019 and Aug 2, 2019 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2019Break; Break

  THE MANUFACTURER WAS INFORMED THAT DURING A THERAPEUTIC PROCEDURE, THE MIDDLE PIECE OF THE CAUTERY LOOP AT THE DISTAL END OF THE ELECTRODE BROKE OFF AND FELL INSIDE THE PATIENT'S URINARY BLADDER. THE SURGEON RETRIEVED THE DEVICE FRAGMENT BY FLUSHING/SUCTION OUT WITH STERILE WATER. THERE WAS NO MEDICAL TREATMENT REQUIRED AND THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8857127 ↗