Olympus WA22039CRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14042761051603), received between Oct 13, 2021 and Oct 13, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 8, 2023Class IIOpen, 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 13, 2021Material Separation; Material Separation

  IT IS REPORTED BY THE CUSTOMER (AND IN MW5103123), DURING A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) USING A SINGLE USE HF-RESECTION ELECTRODE, THE ELECTRODE BROKE INSIDE THE PATIENT'S URETHRA. MOST OF THE DEVICE FRAGMENTS WERE REMOVED USING OTHER UNSPECIFIED INSTRUMENTS. POST-OPERATIVE X-RAYS DID NOT DEMONSTRATE ANY RETAINED FOREIGN BODY. THE CUSTOMER COULD NOT CONFIRM IF THERE WERE ANY PROCEDURAL COMPLICATION OR ANATOMICAL CHALLENGES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. THE PATIENT'S CURRENT CONDITION IS REPORTED AS: PATIENT WAS DISCHARGED FROM THIS HOSPITAL ADMISSION. THE SETTINGS USED FOR THE PROCEDURE WERE 120/200 CUT. THE CUSTOMER WAS UNABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE PATIENT, DEVICES USED, OR EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12624268 ↗