NA 72203129Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010655318), received between Mar 13, 2020 and Mar 13, 2020 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 13, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED SURGERY, AFTER TURNING OFF AND ON THE 5.5 MM HIGH VISIBILITY BLADE, IT DID NOT SPIN AND GOT STUCK SO THE PRODUCT BEGAN TO HEAT AND THEN BURNED. ALTHOUGH IT IS UNKNOWN HOW THE SURGERY WAS COMPLETED, THE SURGERY WAS NOT SIGNIFICANTLY DELAYED. THE PATIENT WAS NOT HARMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9831061 ↗