ClearanceBrief
Recall Z-2156-2015 ยท GEX Powered Laser Surgical Instrument

American Medical Systems Innovation Center - Silicon Valley

Sureflex 150 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragm

DateJul 21, 2015 (initiated May 28, 2015)
StatusTerminated
Reasonvalidation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products
Root causeReprocessing Controls
ActionUrgent Medical Device Field notification letters were sent on June 9, 2015. Translation for countries out of the US will be conducted. Communications are being coordinated by the Prostate Health QA Director. Urgent Medical Device Field notification Letters advised customers of the issue and list all affected products with name and model numbers. Any SureFlex Reuseable Fibers which have not been used but are in inventory and with the 3 year shelf life should be returned as per instructions enclosed. Any of the SureFlex devices in inventory that have been used should be discarded or returned. Al
Quantity~13,710 units - total all affected devices
DistributionWorldwide Distribution - US Nationwide in the countries of: Argentina France Morocco, South Africa, Australia, Germany, Netherlands, Spain, Austria, Greece, New Zealand, Sri Lanka, Belgium, Guatemala, Norway, Switzerland, Bolivia, India, Panama, Thailand, Brazil, Ireland, Peru, Turkey, Canada, Isra
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K050108SUREFLEX AND ACCUFLEX LASER LITHOTRIPSY FIBERS
Innovaquartz, Mar 14, 2005