CUSA® Clarity C7418SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780466161), received between Mar 10, 2023 and Jan 31, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Crack” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 31, 2025Device Handling Problem; Device Handling Problem

  N/A.

  Patient problems: Bacterial Infection

  MAUDE report 21283467 ↗
• MalfunctionMar 10, 2023Crack; Power Problem; Crack; Power Problem

  A FACILITY REPORTED THAT THE CUSA CLARITY 23KHZ TOUGH TISSUE TIP (C7418S) WAS USED FOR A CASE AS CEM NOSE WAS NEEDED. THE HANDPIECE PASSED THE INITIAL TEST AND THE SURGEON PROCEEDED WITH THE CASE. 5 MINUTES LATER, THE AMPLITUDE DROPPED TO 20% AND THE SURGEON COULD NOT FRAGMENT ANY TUMOR. TROUBLESHOOTING WAS DONE BY REMOVING THE TIP, RE-TORQUING, BUT THE 2ND AND 3RD TESTS FAILED AS WELL. IN ORDER TO CONTINUE THE PROCEDURE, A DECISION WAS MADE TO USE 36KHZ HANDPIECE. AFTER THE CASE, THE 23KHZ TIP WAS INSPECTED AND A SMALL CRACK WAS NOTED ON THE SHAFT. THE EVENT LED TO INCREASED SURGERY TIME OF 30 MINUTES; HOWEVER, THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16526476 ↗