Olympus WA22558CRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 14042761071526), received between Oct 29, 2018 and Mar 13, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 16, 2026.

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.

• MalfunctionMar 13, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED, TWO HF RECESSION ELECTRODES RECEIVED FOR THE PROCEDURE WERE BENT. THE ISSUE OCCURRED DURING THE DEMONSTRATION. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18896070 ↗
• MalfunctionSep 10, 2020Break; Melted; Break; Melted

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC ENUCLEATION OF THE PROSTATE PROCEDURE, THE LOOP WIRE OF THE HF RESECTION ELECTRODE MELTED AND FRAGMENTS MAY HAVE FALLEN INTO THE PATIENT¿S BLADDER. HOWEVER, NO FRAGMENTS COULD BE LOCATED INSIDE THE PATIENT. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SIMILAR DEVICE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10512707 ↗
• MalfunctionOct 29, 2018Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL ENUCLEATION OF THE PROSTATE WITH BIPOLAR (TUEB) PROCEDURE, THE LOOP WIRE OF THE HF RESECTION ELECTRODE BROKE OFF AND FELL INSIDE THE PATIENT'S BLADDER. IT IS ASSUMED THAT THE FRAGMENT WAS FLUSHED OUT WITH IRRIGATION FLUID SINCE NO FOREIGN OBJECTS WERE DISCOVERED INSIDE THE BLADDER. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME SET OF EQUIPMENT AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8013549 ↗