CUSA® Clarity C7421SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780536369), received between Nov 15, 2024 and Nov 15, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Radiation Leak” (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 18, 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.

• InjuryNov 15, 2024Radiation Leak; Radiation Leak

  A FACILITY REPORTED THAT THE USA CLARITY 23KHZ SINGLE SIDED BONE TIP (C7421SEA) WAS USED FOR AN "INTRACRANIAL TUMOR REMOVAL SURGERY¿, AND WHEN CUTTING THE INTERNAL AUDITORY MEATUS, DAMAGE WAS OBSERVED IN THE DURA MATER. THE SETTING OF THE DEVICE WHEN THE ISSUE OCCURRED: AMPLITUDE 80, TISSUE SELECT 0, ASPIRATION 90, IRRIGATION 10. THE SURGEON WAS NOT SURE IF THE DEVICE TOUCHED THE DURA MATER AND SUSPECTED THAT THE DEVICE IRRADIATED ULTRASONIC WAVES. HOWEVER, THE SURGEON WAS INITIALLY PLANNING TO MAKE AN INCISION IN THE PART OF DURA MATER THAT WAS DAMAGED; THEREFORE, THE EVENT DID NOT INTERFERE WITH THE OVERALL PROCEDURE. THERE WAS NO DELAY IN SURGERY, AND THE SAME DEVICE WAS USED TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION RECEIVED INDICATING THE FOLLOWING: THE DEVICE DID NOT FALL OUT OF THE "DUTY CYCLE". ITS OUTPUT SETTING DURING PROCEDURE WAS AS FOLLOWS; AMPLITUDE 80, TISSUE SELECT 0, ASPIRATION 90, IRRIGATION 10. WHEN THE SALES REP ATTENDED THE SURGERY, IT SEEMED LIKE THE SURGENT DID NOT PUT TOO MUCH LOAD ON THE TIP. OTHER OUTPUT DEVICES WERE NOT USED AT THE SAME TIME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20699155 ↗