DeRoyal 88-000002Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756053280), received between Aug 9, 2024 and Aug 9, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  A USER FACILITY REPORTED, "COAGULATOR BUTTON AND CUT BUTTON WORKED INCORRECTLY, THE BUTTONS DID THE OPPOSITE OF WHAT WAS LABELED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19954378 ↗
• MalfunctionAug 9, 2024Self-Activation or Keying; Self-Activation or Keying

  A USER FACILITY REPORTED, "OUR FACILITY USES YOUR BOVIE PENCILS, REF# 88-000002, AND WE HAD AN ISSUE DURING A TOTAL KNEE REPLACEMENT THIS MORNING. THE BOVIE'S "CUT" ACTIVATED ON ITS OWN AND STAYED ACTIVATED. THIS HAS HAPPENED IN THE PAST BUT THE PENCIL AND PAD WERE NOT SAVED FROM THE PREVIOUS INCIDENT. OUR BOVIE MACHINE WAS INSPECTED AND CLEARED FROM THE PREVIOUS INCIDENT. AFTER TODAY'S INCIDENT, THE BOVIE WAS SWITCHED WITH A DIFFERENT BRAND AND THE ISSUE WAS NOT DUPLICATED. THE DEFECTIVE BOVIE WAS RE-INSERTED AND IT ACTIVATED WITHOUT THE PENCIL BEING PUSHED. THE LOT NUMBER OF THIS BOVIE IS 58744504. WE HAVE PRESERVED THE BOVIE PENCIL AND CAUTERY TIP FOR FURTHER INSPECTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19951318 ↗