FDA Adverse Event Malfunction Summary report: N

GREENLIGHT ADDSTAT

MDR report key: 2092691 · Received April 6, 2011

Report

Report Number: 2937094-2011-00562
Event Type: Malfunction
Date Received: April 6, 2011
Date of Event: September 20, 2010
Report Date: September 20, 2010
Manufacturer: AMS INNOVATION CENTER-SILICON VALLEY
Product Code: GEX
PMA / PMN Number: K062719
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: DE, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE EVENT DESCRIPTION THE CUSTOMER REPORTED TO AMS DID NOT INDICATE A POTENTIAL PATIENT SAFETY ISSUE. THE DEVICE WAS SUBSEQUENTLY RETURNED TO AMS AND ANALYZED. THE INFORMATION FROM THIS FAILURE ANALYSIS WAS RECEIVED 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 FRACTURED AND PARTIALLY BROKE OFF. THE FIBER HAD A BROKEN OR MELTED BEVEL AREA. PART OF THE FIBER CAP BROKE OFF OR THE ENTIRE CAP SLID OFF. BURNT GLUE ON THE BEVEL PORTION OF THE FIBER WAS GENERALLY EVIDENT. THIS DEVICE FAILURE IS ASSOCIATED WITH A LACK OF COOLING. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE TISSUE CONTACT AND EMBEDMENT. THE PRODUCT LABELING (PRODUCT INSERT (B)(4)) WARNS THAT TISSUE CONTACT OR TISSUE PROBING MAY CAUSE FIBER DAMAGE OR BREAKAGE. THE PRODUCT LABELING ALSO WARNS OF POSSIBLE CAP DETACHMENT IN THE PATIENT 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 EFFICIENCY AT 42,351 JOULES. A FAILURE ANALYSIS, CONDUCTED BY AN AMERICAN MEDICAL SYSTEMS QUALITY ENGINEER, DISCLOSED THAT THE FIBER CAP FRACTURED AND PARTIALLY BROKE OFF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	GREENLIGHT ADDSTAT	SURGICAL FIBER	GEX	AMS INNOVATION CENTER-SILICON VALLEY	NA	012H

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other