CUSA® Clarity C7523Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780466215), received between May 9, 2024 and May 9, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Premature Activation” (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 9, 2024Premature Activation; Premature Activation

  A FACILITY REPORTED THAT THE THE CUSA CLARITY 23KHZ CEM NOSECONE (C7523 WAS USED IN A LAPAROSCOPIC HEPATECTOMY PROCEDURE, AND 30 MINUTES AFTER LIVER SECTION STARTED, THE DEVICE TURNED ON EVEN THOUGH THE BUTTON ON THE CEM NOSECONE WAS NOT PRESSED. THE PATIENT¿S SKIN GOT BURNED APPROXIMATELY 1CM IN DIAMETER, SINCE THE DEVICE WAS PLACED RIGHT UNDER A PORT. THE SURGEON STOPPED USING THE DEVICE AND THE PROCEDURE WAS COMPLETED USING A STANDARD NOSECONE. ACCORDING TO FURTHER INVESTIGATION, ONE OF THE CONNECTOR PINS WAS MISSING AND THE MISSING PIN WAS NOT RETURNED. ACCORDING TO THE SALES REP, THE PIN WAS REMOVED AT THE HOSPITAL. THE GENERATOR THAT WAS USED WITH THE PRODUCT WAS ZERUK / MERA.

  Patient problems: Burn(s)

  MAUDE report 19282657 ↗