Class 2 Device Recall Assembly, Patient Side Cart

• Date Initiated by Firm: May 09, 2014
• Date Posted: June 04, 2014
• Recall Status: Terminated on June 04, 2014
• Recall Number: Z-1718-2014
• Recall Event ID: 68358
• 510(K)Number: K131861
• Product Classification: System,surgical,computer controlled instrument - Product Code NAY
• Product: Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000. The patient-side cart is positioned at the operating room table and contains four arms that are positioned over the target patient anatomy. The endoscope attaches onto any arm. The patient-side assistant attaches/detaches the endoscope and instrument intra-operatively.
• Code Information: lot 380652-20
• Recalling Firm/ Manufacturer: Intuitive Surgical, Inc.; 1266 Kifer Rd Bldg 100; Sunnyvale CA 94086-5304
• For Additional Information Contact: Mark Johnson; 408-523-2100
• Manufacturer Reason for Recall: Torque wrenches used to tighten certain PSC bolts were out of calibration. This could lead to over- or under-tightening of bolts that may result in system faults, mechanical sound (e.g. scraping, squeaking, rattling), cracks or vibration in the system.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Intuitive sent an Urgent Medical Device Correction letter dated May 13, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. All personnel who use the device should be notified of the issue and the acknowledgement form completed and returned. Intuitive reps will visit each affect sites to install a replacement PSC and ensure that it is properly integrated with the Da Vinci. For questions contact Intuitive Surgical at 800-876-1310 Option 3 (Monday - Friday 6 am to 5 pm PST).
• Quantity in Commerce: 2
• Distribution: Medical facilities in TX and FL
• 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 = NAY