Olympus WA22606DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14042761075470), received between Mar 20, 2019 and Mar 20, 2019 — classified as 1 injury.

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.

• InjuryMar 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING A HYSTEROSCOPIC TRANSURETHRAL RESECTION IN SALINE (TURIS) PROCEDURE, THE PATIENT SUSTAINED A PERFORATION OF THE UTERINE WALL. THE PROCEDURE WAS THEN CONVERTED TO OPEN SURGERY (LAPAROTOMY) TO TREAT THE PERFORATION. NO FURTHER INFORMATION WAS PROVIDED, BUT THERE WERE NO REPORTS OF ANY DEVICE MALFUNCTIONS.

  Patient problems: Uterine Perforation

  MAUDE report 8435604 ↗