FDA Adverse Event Malfunction Summary report: N

GREENLIGHT MOXY FIBER OPTIC

MDR report key: 3042277 · Received April 1, 2013

Report

Report Number: 2937094-2013-00419
Event Type: Malfunction
Date Received: April 1, 2013
Date of Event: December 20, 2012
Report Date: January 15, 2013
Manufacturer: AMERICAN MEDICAL SYSTEMS
Product Code: GEX
PMA / PMN Number: K120870
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

FIBER ANALYSIS: A RADIAL FRACTURE OF THE GLASS CAP WAS FOUND DISTAL TO THE FIBER/CAP FUSION ZONE; THE GLASS CAP/FIBER PROXIMAL TO THE FRACTURE WAS FOUND TO ROTATE INDEPENDENTLY OF THE METAL CAP. THE GLASS CAP DISTAL TO FRACTURE REMAINS ATTACHED TO METAL CAP. THE METAL CAP SHOWS CHAR AND BURNT DETRITUS. THE IDENTIFIED ISSUES MAY ACTIVATE THE FIBERLIFE FUNCTION WHICH WOULD MODULATE THE POWER SHOWING A PULSING BEAM OR THE SYSTEM WOULD BE PLACED INTO STANDBY MODE. THIS ISSUE MAY ALSO CAUSE FORWARD-FIRING OF THE SIDE-FIRING SURGICAL FIBER. THE MOST PROBABLE ROOT CAUSE THAT CONTRIBUTED TO THIS FAILURE WAS SUSPECTED TO BE LOCALIZED HEAT ACCUMULATION / USER HANDLING DUE TO ANATOMICAL / PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

Description of Event or Problem · 1

IT WAS REPORTED THAT WHILE USING A SURGICAL FIBER DURING A PROSTATE PROCEDURE, DIMINISHED TISSUE VAPORIZATION EFFICIENCY WAS OBSERVED; A SECOND FIBER WAS CONNECTED AND THE CASE WAS CONTINUED. AT 157,471 JOULES OF USE, DIMINISHED TISSUE VAPORIZATION EFFICIENCY WAS OBSERVED FROM THE SECOND FIBER. THE CASE WAS COMPLETED USING A THIRD FIBER. PT OUTCOME: "NO HARM TO PT." THIS REPORT IS FOR THE SECOND FIBER USED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
131947	GREENLIGHT MOXY FIBER OPTIC	POWERED SURGICAL LASER INSTRUMENT	GEX	AMERICAN MEDICAL SYSTEMS	10-2400	242B

Patients

Seq	Age	Sex	Outcome	Treatment
1