Olympus WA47051CRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14042761052440), received between Apr 24, 2019 and Apr 24, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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

• MalfunctionApr 24, 2019Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A TRANSCERVICAL RESECTION OF FIBROIDS (TCRF) PROCEDURE, THE LOOP WIRE AT THE DISTAL END OF THE HF RESECTION ELECTRODE BROKE INSIDE THE PATIENT'S UTERUS BUT WAS RETRIEVED IN ONE PIECE. A SECOND ELECTRODE WAS THEN USED TO CONTINUE THE PROCEDURE, WHICH BECAME LOOSE AND BROKE WHEN TRYING TO REMOVE IT. IT IS UNKNOWN WHETHER OR NOT A FRAGMENT REMAINED INSIDE THE PATIENT. THE INTENDED PROCEDURE WAS THEN SUCCESSFULLY COMPLETED WITH A SIMILAR DEVICE (MYOSURE) AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY. AN X-RAY WAS TAKEN TO CONFIRM THAT NO FRAGMENTS REMAINED INSIDE THE PATIENT, THE RESULTS OF WHICH ARE NOT YET AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8544012 ↗