Olympus A22251ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04042761021562), received between Aug 14, 2018 and Apr 18, 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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 18, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED, THE HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12° AND 30° DISPLAYED A BENT ELECTRODE TIP. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR A TRANSCERVICAL RESECTION PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19134392 ↗
• MalfunctionOct 19, 2022Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION (TUR) PROCEDURE THE BALL PART OF THE ROLLER ELECTRODE WAS MISSING WHEN THE ELECTRODE WAS PULLED OUT THROUGH THE URETHRA. THE STAFF COULD NOT FOUND THE MISSING PART AND ASSUMES THAT THE ROLLER MAY HAVE BEEN ASPIRATED ALONG WITH THE TISSUE. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SIMILAR DEVICE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 15630844 ↗
• MalfunctionAug 14, 2018Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE ROLLER AT THE DISTAL END OF THE HF RESECTION ELECTRODE DETACHED AND FELL INSIDE THE PATIENT¿S BLADDER. HOWEVER, NO FRAGMENT REMAINED INSIDE THE PATIENT SINCE IT WAS REPORTEDLY RETRIEVED. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7780434 ↗