CUSA® Clarity C7002Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780126256), received between Feb 25, 2022 and Sep 6, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (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.

• MalfunctionSep 6, 2024Output below Specifications; Output below Specifications

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3006697299-2024-00135: A FACILITY REPORTED THAT THE CUSA CLARITY FOOTSWITCH (C7002) VOLTAGE WAS CHECKED PRIOR TO SURGERY AND WAS BELOW THE SPECIFIED VALUE. THE DEVICE WAS REBOOTED, BUT IT COULD NOT BE USED, AND ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. SURGICAL DELAY WAS MORE THAN 30 MINUTES. THE FOLLOWING DAY, A COMPANY REPRESENTATIVE VISITED THE FACILITY TO CHECK THE DEVICE, AND RE-INSTALLED THE SOFTWARE WHICH RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20159191 ↗
• MalfunctionFeb 25, 2022Device Remains Activated; Device Remains Activated

  A FACILITY REPORTED THAT DURING THE OPERATION OF THE CUSA CLARITY FOOTSWITCH (C7002) WHEN PRESSING THE ORANGE PEDAL THE PEDAL STAYS IN ACTIVATION MODUS. THEY CHANGED THE FOOT PEDAL TO ANOTHER CUSA CLARITY. THE EVENT LED TO INCREASE SURGERY TIME FOR 5 MINUTES; HOWEVER, THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13600087 ↗