inforMED
MalfunctionJOS

SUREFIT

Received Nov 14, 2016 · Event occurred Nov 8, 2016

Report 6099802 · MDR key 6099802

Device

Generic name

Bovie Pad

Manufacturer

Conmed Corporation

Catalog number

410-2000

Lot number

201506265

Product problems

  • Thermal Decomposition of Device
  • Energy Output Problem

Patient

30 YR

  • Burn, Thermal
  • Burn, Thermal

Narrative

Description of Event or Problem

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.