SUREFIT 410-2000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30653405033831), received between Jan 5, 2016 and Apr 19, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2023Disconnection

  BOVIE PAD FULLY ADHERED TO PATIENT'S SKIN, HOWEVER, BOVIE MACHINE ALARMING DISCONNECTED PAD. BOVIE MACHINE CLEARED VIA MEDICAL ENGINEERING AS WORKING APPROPRIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16768362 ↗
• InjuryJan 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED ON MAUDE ADVERSE EVENT REPORT NUMBER (B)(4): "A (B)(6) MALE ADMITTED FOR AN ELECTIVE NEUROSURGICAL PROCEDURE ON (B)(6) 2016. AT THE START OF THE PROCEDURE, THE NEUROSURGEON NOTED THE BOVIE WAS NOT DELIVERING THE DESIRED POWER. THE PROCEDURE WAS STOPPED AS THE CIRCULATING RN TRACED THE ELECTROSURGICAL EQUIPMENT FROM PEN TO GENERATOR AND NOTED "GREEN" LIGHT PRESENT INDICATING GOOD GROUNDING AND CAN PROCEED. THEN CONTINUED TRACING TO PT AT BOVIE PAD. THE BOVIE PAD WAS REMOVED WHICH REVEALED A SMALL BURN AT THE EDGE OF THE PAD ON THE PT'S RIGHT LATERAL THIGH. THE NEUROSURGEON DECIDED TO ABORT THE CASE DUE TO THE BURN. A GENERAL SURGEON ASSESSED THE SITE AND EXCISED THE BURNED TISSUE. THIS RESULTED IN A 2CM X 6 CM INCISION WOUND THAT WAS CLOSED WITH NYLON SUTURES AND DRESSING APPLIED. SUTURES TO BE REMOVED BY GENERAL SURGEON IN ONE WEEK. ORIGINAL NEUROSURGICAL PROCEDURE TO BE RESCHEDULED IN 2-3 WEEKS." NO CONTACT INFORMATION FOR REPORTER OR USER FACILITY IS LISTED ON MAUDE REPORT AND THEREFORE, TO DATE, THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT'S LATEST CONDITION OR ANY INDICATION OF LONG TERM ADVERSE EFFECT HAS OCCURRED.

  Patient problems: Burn(s)

  MAUDE report 6266723 ↗
• InjuryJan 5, 2016Insufficient Device Problem Information

  THE END-USER FACILITY REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, A CONMED SUREFIT DISPERSIVE ELECTRODE WAS UTILIZED AND PLACED ON THE PATIENT'S RIGHT THIGH. REPORTEDLY, UPON COMPLETION OF THE SURGERY, AND WHEN THE DISPERSIVE PAD WAS REMOVED, A SECOND DEGREE BURN TO THE PATIENT'S RIGHT THIGH WAS IDENTIFIED AT THE SITE OF THE DISPERSIVE ELECTRODE. THE "BURN" WAS APPROXIMATELY 1 X 1.5 INCHES AND OVAL SHAPED. TREATMENT TO THE REPORTED "BURN" WAS SILVADENE OINTMENT AND A NON-ADHERENT BANDAGE. THERE WAS NO REPORT OF ANY LONG TERM CONSEQUENCES THAT RESULTED FROM THE REPORTED INCIDENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 5343595 ↗