—#127460

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.

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K131861
Affected lot / code info: lot 380652-20

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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).

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 1266 Kifer Rd, Bldg 100, Sunnyvale, California 94086-5304

Distribution

Distribution pattern: Medical facilities in TX and FL

Timeline

Recall initiated: 2014-05-09
Posted by FDA: 2014-06-04
Terminated: 2014-06-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #127460. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.