CUSA® Clarity C7411SEARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780126409), received between May 5, 2023 and May 5, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Overheating of Device” (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.

• InjuryMay 5, 2023Overheating of Device; Overheating of Device

  THIS IS 2 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3006697299-2023-00044. 3006697299-2023-00046. A FACILITY REPORTED THAT CUSA CLARITY 36KHZ CURVED EXTENDED MICROTIP (C7411SEA) WAS USED DURING A "CRANIOTOMY OCCIPITAL RIGHT SIDE" FOR TUMOR REMOVAL, AND THE PATIENT RECEIVED A SUPERFICIAL BURN ON THE RIGHT SCAPULA AND WAS GIVEN FIRST AID TREATMENT WITH BETADINE AND A DUODERM DRESSING. THE HANDPIECE WAS APPARENTLY RESTED ON THE SCAPULA ON TOP OF THE SURGICAL DRAPE. THE SURGEON'S GOWN HAD A BURN THROUGH HIS SURGICAL GOWN BUT HAD NO PERSONAL INJURY. THERE WAS NO DELAY IN SURGERY REPORTED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 16877461 ↗