FDA Adverse Event Malfunction Summary report: N

HIGH TEMPERATURE CAUTERY BOVIE

MDR report key: 24376180 · Received February 18, 2026

Report

Report Number
MW5183972
Event Type
Malfunction
Date Received
February 18, 2026
Date of Event
February 6, 2026
Report Date
February 13, 2026
Manufacturer
MEDLINE INDUSTRIES, LP - NORTHFIELD
Product Code
GEI
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
OR, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

DEVICE INVOLVED WAS MEDLINE HIGH TEMPERATURE CAUTERY (1/2 INCH SHAFT WITH FINE TIP) REF # ESCT001, LOT #6083729 EXP 2028-11-10. DETAILS OF THE EVENT: A SMALL FIRE OCCURRED IN AN OPERATING ROOM DURING A UROLOGY PROCEDURE. A SINGLE-USE, BATTERY-POWERED ELECTROCAUTERY DEVICE WAS PRESENT, ACCORDING TO STAFF IN THE ROOM, WAS NOT ACTIVELY IN USE AT THE TIME OF THE EVENT. THE DEVICE APPEARS TO HAVE SPARKED, IGNITING A RAYTEC SPONGE. THE SURGEON RESPONDED IMMEDIATELY BY REMOVING THE IGNITED MATERIALS AND SUBMERGING SALINE, EXTINGUISHING THE FIRE. THE RESPONSE WAS RAPID AND EFFECTIVE. THERE WERE NO INJURIES TO THE PATIENT OR STAFF, AND THE PATIENT REMAINED STABLE THROUGHOUT THE EVENT. THE CIRCULATOR NOTIFIED CHARGE, WHO ESCALATED TO MANAGEMENT. UPON ARRIVAL, THE MANAGER CONFIRMED THAT THE FIRE WAS EXTINGUISHED AND ALL PARTIES WERE SAFE. THE INTRAOPERATIVE FIRE POLICY WAS ACCESSED ON MCN AND FOLLOWED APPROPRIATELY. ALTHOUGH THE FIRE HAD ALREADY BEEN EXTINGUISHED, THE FIRE ALARM WAS PULLED PER POLICY, 4-4444 WAS CALLED, AND THE ADMINISTRATOR ON DUTY WAS NOTIFIED. SURGERY CONTINUED, AS THE PATIENT REMAINED SAFE. FACILITIES RESPONDED AND TOOK CUSTODY OF THE ELECTROCAUTERY DEVICE, THE RAYTEC SPONGE, AND THE SALINE PITCHER. THE AOD EVALUATED STAFF AND THE SITUATION IN PERSON. THE EVENT WAS REPORTED TO HOSPITAL LEADERSHIP.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
435964 HIGH TEMPERATURE CAUTERY BOVIE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDLINE INDUSTRIES, LP - NORTHFIELD ESCT001 6083729

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown