Class 2 Device Recall VSII

• Date Initiated by Firm: March 21, 2011
• Date Posted: March 08, 2012
• Recall Status: Terminated on March 08, 2012
• Recall Number: Z-1192-2012
• Recall Event ID: 61279
• 510(K)Number: K081102
• Product Classification: Endoscope, neurological - Product Code GWG
• Product: Visionsense Stereoscopic Vision System, Brand name VSII, Model/Part Numbers 172-0030 and 172-0040 --- Classification Name: Neurological Endoscope --- NOTE: Model Numbers 172-0032, 172-0044, 172-0070, 172-0072, 172-0080 were also included in the firm's recall action but these never entered US commerce. These were distributed directly from Israel to the foreign consignees. --- The VSII is intended for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures. These devices do not carry an expiration date. However, they are automatically taken out of service and replaced after 40 uses.
• Code Information: Model/Part Number 172-0030 serial numbers: 370-1330, 370-1379, 370-1469, 370-1316, 370-1452, 370-1482, 370-1335, 370-1450, 370-1479, 370-1406, 370-1443; Model/Part Number 172-0040 serial numbers: 370-1457 DEMO, 370-1477 DEMO, 370-1345 DEMO, 370-1438 DEMO, 370-1396 DEMO, 370-1437 DEMO, 370-1428 DEMO, 370-1470 DEMO, 370-1398 DEMO, 370-1440 DEMO
• FEI Number: 3003143838
• Recalling Firm/ Manufacturer: Visionsense, Ltd.; 20 Hamagshimim St.; Petach, Tikva Israel
• Manufacturer Reason for Recall: A complaint was received and a unit returned that exhibited the metal and glass shaft window becoming dislodged during scope cleaning. Additionally, during in-process visual inspection of the metal and glass shaft window sub-assembly from a specific batch that was received from the supplier it was noted that the window at the tip of the scope was not seated properly. It was determined that the wi
• FDA Determined Cause: Nonconforming Material/Component
• Action: Visionsense Ltd. sent URGENT DEVICE RECALL and URGENT DEVICE RECALL/FIELD SAFETY NOTICE letter dated March 21, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer and included a return "fax" form in the recall communication package. The letters were sent via UPS express service. All direct consignees were contacted, and follow up phone calls conducted if needed. The recall required the return of all affected units for inspection and/or repair. Visionsense provided a return authorization number and packing instructions to the consignees.
• Quantity in Commerce: Domestic - 17 units; Foreign - 4 units
• Distribution: Worldwide Distribution - USA including Arizona, Georgia, Pennsylvania, California, and the country of Turkey
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GWG