CUSA® Clarity C7417SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780126386), received between Feb 13, 2025 and Nov 26, 2025 — classified as 3 malfunctions.

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 18, 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.

• MalfunctionNov 26, 2025Crack; Overheating of Device; Crack; Overheating of Device

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23662954 ↗
• MalfunctionSep 22, 2025Product Quality Problem; Product Quality Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23110500 ↗
• MalfunctionFeb 13, 2025Material Fragmentation; Material Fragmentation

  A FACILITY REPORTED THAT THE CUSA CLARITY 36KHZ CURVED EXTENDED SHEARTIP (C7417S) BROKE DURING TUMOR REMOVAL. ALL BROKEN PARTS WERE RECOVERED, BUT THERE WAS THE POSSIBILITY OF THE PRODUCT REMAINING IN THE PATIENT¿S BODY. OTHER DEVICES (SCISSORS AND BIPOLAR) WERE USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY OR DELAY IN SURGERY. ADDITIONAL INFORMATION NARRATIVE RECEIVED AS FOLLOWS: THERE WAS NO PROBLEM WITH HOW THE TIP WAS ATTACHED. IT WAS ATTACHED BY FOLLOWING THE GUIDELINES. SINCE THE TUMOR WAS COMPARATIVELY HARD, THERE'S A POSSIBILITY THAT THE STRONG FORCE WAS APPLIED WHEN USING IT. HOWEVER, NO EXCESSIVE LOAD WAS APPLIED INTENTIONALLY. THE DOCTOR IS NOT SURE THOUGH, HE ASSUMES THAT THE DEVICE WAS NOT CONTINUOUSLY USED FOR MORE THAN 10 MINUTES. THE DEVICE WAS USED FOR AROUND 30 MINUTES PER EACH TIP. THE PATIENT IS CURRENTLY STABLE, AND AN IMAGING TEST SHOWED NO SIGNS OF REMAINING PRODUCT. FOR WHAT TYPE OF PROCEDURE WAS PRODUCT OR DEVICE USED? EXTERNAL DECOMPRESSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21380295 ↗