FDA Adverse Event Malfunction Summary report: N

ULTRA MD40

MDR report key: 832525 · Received March 2, 2007

Report

Report Number
832525
Event Type
Malfunction
Date Received
March 2, 2007
Date of Event
March 1, 2007
Report Date
March 2, 2007
Manufacturer
LASER ENGINEERING
Product Code
GEX
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA, US

Narratives

Description of Event or Problem · 1

OPERATING ROOM WAS SET UP PREOPERATIVELY; CO2 LASER UNIT IN ROOM AND CONNECTED WITH MICROSCOPE MICROMANIPULATOR LASER UNIT FOR FUNCTION AND ALIGNMENT OF AIMING BEAM. LASER TESTED. TEST DEMONSTRATED CO2 LASER WAS FUNCTIONING PROPERLY. INTRAOPERATIVELY, SAFETY MEASURES WERE MET, SALINE MOISTENED GAUZE ON EYES OF THE PATIENT, SALINE MOISTENED GREEN TOWELS ON AND AROUND HEAD, NECK AND FACE (THE OPERATIVE FIELD). TIME OUT WAS PERFORMED. INTRAOPERATIVELY, LASER STATUS (READY AND STAND-BY) WAS VERBALLY COMMUNICATED BY SCRUB TECHNICIAN. AT 0827 A FLARE OCCURRED AT THE SITE OF THE ENDOTRACHEAL TUBE THAT WAS IN THE TRACHEAL STOMA SITE. THE FLARE WAS EXTINGUISHED IMMEDIATELY BY PHYSICIAN. ENDOTRACHEAL TUBE REMOVED AND AIRWAY IRRIGATED WITH SALINE; NEW ENDOTRACHEAL TUBE PLACED FOLLOWED BY REPEAT BRONCHOSCOPY. THE ENDOTRACHEAL TUBE WAS FOUND TO BE A RUSH 4,5 TUBE REF#103600 SIZE I.D.MM 4,5 LOT#04491 EXP 2009-10. THE TUBE WAS SEQUESTERED. THE SSI LASER ENGINEERING ULTRA MD40 (MODEL MD 40) LASER MACHINE WAS TAKEN OUT OF SERVICE AND PLACED IN LOCKED CONSIGNMENT AREA AND WILL BE CHECKED FOR FUNCTIONALITY BY CLINICAL ENGINEERING AND/OR MANUFACTURER. PER CLINICAL ENGINEERING,THE LASER COMPANY WILL NEED TO SEND SOMEONE OUT TO CHECK THE LASER. PATIENT WAS EXTUBATED PRIOR TO LEAVING THE OR, HAD A TRACH TUBE IN PLACE, AND MOVING AT WILL. BREATHING ON OWN AND TRANSPORTED TO THE PACU.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ULTRA MD40 LASER, CO2 GEX LASER ENGINEERING ULTRA MD40 (MODEL MD 40) *
2 RUSCH TUBE, ENDOTRACHEAL BTR RUSCH, INC. * 04491

Patients

Seq Age Sex Outcome Treatment
1 3 YR