FDA Adverse Event Malfunction Summary report: N

SUREFLEX FIBERS

MDR report key: 3760963 · Received April 21, 2014

Report

Report Number: 2937094-2014-00306
Event Type: Malfunction
Date Received: April 21, 2014
Date of Event: April 1, 2014
Report Date: April 1, 2014
Manufacturer: AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
Product Code: GEX
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT EVALUATION: FAILURE ANALYSIS FOR FIBER (B)(4): THE FIBER WAS RETURNED WITH 2 SECTIONS; FIRST SECTION: THE LENGTH OF THE FIRST SECTION WAS 7 FEET 5.75" AND INCLUDED THE DISTAL END; THE GLASS DISTAL END OF THE FIBER APPEARED IN GOOD CONDITION WITH MODERATE DEVITRIFICATION AND EXTENDED 3MM FROM THE BLUE JACKET; THE BLUE OUTER SHEATH JACKET EXHIBITED SIGNS OF BLACK MARKS 4MM FROM THE DISTAL TIP; THE BLUE OUTER SHEATH JACKET EXHIBITED SIGNS OF MELTING AT THE FRACTURE SIDE; SECOND SECTION: THE LENGTH OF THE SECOND SECTION WAS 3 FEET 8.5" AND INCLUDED THE CONNECTOR; THE GLASS FIBER EXHIBITED SIGNS OF FRACTURE AT THE LOCATION OF THE FRACTURE AND EXTENDED 0.5" FROM THE BLUE JACKET; THE BLUE OUTER SHEATH JACKET EXHIBITED SIGNS OF BLACK MARK/MELTING AT THE LOCATION OF THE FRACTURE. PROBABLE ROOT CAUSE: BASED ON THE PRODUCT ANALYSIS RESULTS, THE PROBABLE ROOT CAUSE OF THE FAILURE IS: EXCESSIVE BENDING; POSSIBLE USER HANDLING ISSUE.

Description of Event or Problem · 1

IT WAS REPORTED THAT WHILE USING THE SURGICAL FIBER THE "FIBER MADE A "CRACKING" NOISE AND THE FIBER SNAPPED CLEAN WITHOUT ANY FORCE APPLIED ON OR TORQUEING THE FIBER". THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. PATIENT OUTCOME: "NO ADVERSE PATIENT OUTCOME".

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
240267	SUREFLEX FIBERS	POWERED LASER SURGICAL INSTRUMENT	GEX	AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)	S-LLF273TG	328B

Patients

Seq	Age	Sex	Outcome	Treatment
1