GREENLIGHT ADDSTAT

Report

Report Number: 2937094-2011-00367
Event Type: Malfunction
Date Received: March 9, 2011
Date of Event: September 10, 2010
Report Date: September 14, 2010
Manufacturer: AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
Product Code: GEX
PMA / PMN Number: K062719
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KS, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE EVENT DESCRIPTION THE CUSTOMER REPORTED TO AMS DID NOT INDICATE A POTENTIAL PT SAFETY ISSUE. THE DEVICE WAS SUBSEQUENTLY RETURNED TO AMS AND ANALYZED. THE INFO FROM THIS FAILURE ANALYSIS WAS REC'D ON (B)(6) 2011 AND THE RESULTS OF THE FAILURE ANALYSIS INDICATED THAT AN MDR WAS REQUIRED. THE FAILURE ANALYSIS DISCLOSED THAT THE FIBER CAP REGION BURNED AND/OR MELTED, THE CAP REMAINED INTACT AND ATTACHED. THE SHRINK TUBE AND/OR FIBER JACKET MELTED AND/OR BURNED. THE BEVELED SECTION MELTED AND EXHIBITED BURNT GLUE. THE FIBER CAP GENERALLY EXHIBITED SOME/ALL OF CHAR, DEVITRIFICATION, CRATER AND MELTED GLASS. THIS DEVICE FAILURE IS ASSOCIATED WITH A LACK OF COOLING. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE HEAT ACCUMULATION. THE PRODUCT LABELING (PRODUCT INSERT 0127-1410) WARNS THAT TISSUE CONTACT OR TISSUE PROBING MAY CAUSE FIBER DAMAGE OR BREAKAGE. THE PRODUCT LABELING ALSO WARNS OF POSSIBLE CAP DETACHMENT IN THE PT AND INSTRUCTIONS FOR RETRIEVING.

Description of Event or Problem · 1

IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2010, THERE WAS A DECREASE IN FIBER VAPORIZATION AT 248,000 JOULES. A FAILURE ANALYSIS, CONDUCTED BY AN AMERICAN MEDICAL SYSTEMS QUALITY ENGINEER, DISCLOSED THAT THE FIBER CAP REGION BURNED AND/OR MELTED, THE CAP REMAINED INTACT AND ATTACHED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	GREENLIGHT ADDSTAT	SURGICAL FIBER	GEX	AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY	NA	019H

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other