FDA Adverse Event Injury Summary report: N

SURGICAL LASER TECHNOLOGIES

MDR report key: 3184072 · Received June 21, 2013

Report

Report Number
3184072
Event Type
Injury
Date Received
June 21, 2013
Date of Event
June 19, 2013
Report Date
June 21, 2013
Manufacturer
PHOTOMEDEX, INC
Product Code
GEX
Adverse Event
Yes
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA, US

Narratives

Description of Event or Problem · 1

DURING A BRONCHOSCOPY WITH YAG LASER PROCEDURE, A FIRE STARTED INSIDE THE ENDOTRACHEAL TUBE DURING LASER ABLATION OF A CARINAL TUMOR. THE TIP OF THE LASER FIBER WAS BURNED OFF AND APPARENTLY LOST IN THE PATIENT. A PORTION OF THE ENDOTRACHEAL TUBE BURNED AND MELTED BOTH THE BRONCHOSCOPE AND THE END OF THE FIBER. BRONCHOSCOPY FOLLOWING THE FIRE DIFFICULT TO ASSESS, AS THERE HAD BEEN EXTENSIVE LASER TREATMENT/FULGURATION PRIOR TO THE FIRE. THE FIRE WAS QUICKLY EXTINGUISHED AND THERE APPEARS TO BE ONLY MINOR INJURY TO THE PATIENT. IT IS NOT CLEAR IF THE FIBER FAILED FIRST AND CAUGHT THE ET TUBE ON FIRE OR IF THE FIRE STARTED FIRST AND MELTED THE FIBER. LASER POWER WAS SET AT 15W AND 0.5 SEC DURATION. LASER IS 1064NM WAVELENGTH. LASER MACHINE WAS TESTED FOLLOWING THE INCIDENT AND POWER OUTPUT WAS FOUND TO BE WITHIN ALLOWABLE TOLERANCE. THE DISTAL END OF THE DAMAGED FIBER APPEARS TO BE FRACTURED, BUT IT IS NOT KNOWN AT WHAT POINT THIS HAPPENED. THE FIBER USED IS A CONTACT TYPE THAT USES A SAPPHIRE OR RUBY TIP AND AIR COOLING. WE HAVE HAD SEVERAL FAILURES IN THE PAST WHERE THE TIPS BURN OFF AND GET LOST.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?DIAGNOSTIC BRONCHOSCOPY / RESECTION OF CARINAL TUMOR.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #3IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #4IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
283519 SURGICAL LASER TECHNOLOGIES POWERED LASER SURGICAL INSTRUMENT GEX PHOTOMEDEX, INC * 226202
283520 SURGICAL LASER TECHNOLOGIES POWERED LASER SURGICAL INSTRUMENT GEX PHOTOMEDEX, INC CLMD/220-100W *
283521 MALLINCKRODT TUBE, TRACHEAL BTR COVIDIEN * *
283522 * BRONCHOSCOPE EOQ OLYMPUS CORPORATION OF THE AMERICAS BF-Q180 *

Patients

Seq Age Sex Outcome Treatment
1 57 YR Required Intervention OLYMPUS BRONCHOSCOPE MALLINCKRODT ENDOTRACHEAL| TUBE