Olympus WT645031Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04042761083287), received between Aug 1, 2023 and Aug 1, 2023 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 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.

• InjuryAug 1, 2023Break; Break

  THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT DURING THE TRANSORAL ROBOTIC RESECTION OF A TUMOR ON THE BASE THE TONGUE, THE FK-WO TORS RETRACTOR SNAPPED WHILE IN THE PATIENT'S MOUTH. THE GAG HAD BEEN PLACED IN THE PATIENT¿S MOUTH, AND THE BLADE SNAPPED IN HALF PRIOR TO THE ROBOT BEING DOCKED AND BEFORE THE RESECTION OF THE TONGUE BASE TUMOR STARTED. THE PROCEDURE WAS DELAYED ABOUT TEN MINUTES AS THE DEVICE WAS REPLACED WITH A SECOND FK RETRACTOR AND THE PATIENT'S ANESTHESIA WAS EXTENDED THE SAME AMOUNT OF TIME. THE TUMOR WAS SUCCESSFULLY RESECTED WITH A DIFFERENT FK RETRACTOR AND THERE WAS NO EXTENDED HOSPITAL STAY. ON INSPECTION THERE WAS NO DAMAGE TO THE PATIENT'S TEETH, HOWEVER POST-OPERATIVELY THE PATIENT COMPLAINED OF HAVING PAIN. ADDITIONAL TREATMENT CONSISTED OF SEVERAL REVIEWS BY THE DENTIST AND IT WAS DETERMINED THE PATIENT HAS NERVE ROOT INJURY TO THE TOOTH. THE DEVICE WAS INSPECTED BEFORE USE AND THERE WERE NO OTHER DEVICES INVOLVED.

  Patient problems: Nerve Damage; Pain

  MAUDE report 17438337 ↗