FDA Adverse Event Malfunction Summary report: N

GREENLIGHT MOXY FIBER OPTIC

MDR report key: 2896640 · Received December 28, 2012

Report

Report Number: 2937094-2012-01334
Event Type: Malfunction
Date Received: December 28, 2012
Date of Event: September 20, 2012
Report Date: September 21, 2012
Manufacturer: AMERICAN MEDICAL SYSTEMS
Product Code: GEX
PMA / PMN Number: K100746
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

ANALYSIS: THE FIBER WAS FOUND TO HAVE A CIRCUMFERENTIAL FRACTURE OF THE GLASS CAP, DISTAL TO THE FIBER/CAP FUSION ZONE; THE FIBER PROXIMAL TO THE FRACTURE WAS FOUND TO ROTATE INDEPENDENTLY OF THE METAL CAP. BURNT ON DETRITUS AND DEVITRIFICATION OF THE CAP OUTPUT WINDOW WAS ALSO OBSERVED. THE FIBER CONDITION WOULD LIKELY RESULT IN ACTIVATION OF THE SYSTEMS FIBERLIFE FUNCTION WHICH WILL MODULATE (PULSE) THE OUTPUT BEAM, RESULTING IN REDUCED TISSUE VAPORIZATION EFFICIENCY AND OR SEND THE SYSTEM TO STANDBY MODE. THE FIBER/CAP CONDITION COULD ALSO RESULT IN FORWARD FIRING CONDITION OF THE SIDE-FIRING SURGICAL FIBER. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE HEAT ACCUMULATION DUE TO TISSUE CONTACT AND OR ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, RESULTING IN FIBER BREAKAGE AND CAP DAMAGE.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE LASER SYSTEM DISPLAYED A MESSAGE TO CLEAN THE FIBER TIP AT 96,342 JOULES OF USE. THE FIBER TIP WAS CLEANED TWICE, HOWEVER THE MESSAGE CONTINUED TO APPEAR. THE FIBER WAS REPLACED AND THE CASE WAS COMPLETED USING A SECOND FIBER. NO PATIENT INJURY WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	GREENLIGHT MOXY FIBER OPTIC	POWERED SURGICAL LASER INSTRUMENT	GEX	AMERICAN MEDICAL SYSTEMS	10-2400	228A

Patients

Seq	Age	Sex	Outcome	Treatment
1				GREENLIGHT XPS LASER SYSTEM AND ACCESSORIES