FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER

Report

Report Number: 3005099803-2011-01574
Event Type: Injury
Date Received: May 18, 2011
Date of Event: April 22, 2011
Report Date: April 22, 2011
Manufacturer: BOSTON SCIENTIFIC - MARLBOROUGH
Product Code: GEX
PMA / PMN Number: K100078
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NE, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED APPROXIMATELY 3 MM OF THE DISTAL TIP WAS RECEIVED SEPARATELY. HANDLING DAMAGE CONTRIBUTED TO THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A PROCEDURE USING A FLEXIVA 1000 LASER FIBER, THE TIP OF THE LASER FIBER DETACHED INSIDE THE PATIENT FOLLOWING 2 TO 3 FIRES OF THE LASER. THE PHYSICIAN REPORTED THAT ONCE HE BEGAN FIRING THE LASER, SMALL FRAGMENTS OF GLASS DETACHED AT THE BLUE CLADDING OF THE FIBER. THE PHYSICIAN RETRIEVED THE TIP OF THE FIBER WITH GRASPING FORCEPS. LASER ENERGY FROM A 100 WATT LUMENIS LASER SET AT .6 -1 JOULES RATE WAS BEING USED WITH THE FIBER.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A PROCEDURE USING A FLEXIVA 1000 LASER FIBER, THE TIP OF THE LASER FIBER DETACHED INSIDE THE PATIENT FOLLOWING 2 TO 3 FIRES OF THE LASER. THE PHYSICIAN REPORTED THAT ONCE HE BEGAN FIRING THE LASER, SMALL FRAGMENTS OF GLASS DETACHED AT THE BLUE CLADDING OF THE FIBER. THE PHYSICIAN RETRIEVED THE TIP OF THE FIBER WITH GRASPING FORCEPS. LASER ENERGY FROM A 100 WATT LUMENIS LASER SET AT .6 -1 JOULES RATE WAS BEING USED WITH THE FIBER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER	POWERED LASER SURGICAL INSTRUMENT	GEX	BOSTON SCIENTIFIC - MARLBOROUGH	M0068403941	1ML0121304

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	100 WATT LUMENIS LASER