Assembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S Surgical System; da Vinci SI Surgical System

FDA device recall Z-0436-2014 · posted 2013-12-03 · Terminated

Recall details

Recalling firm

Intuitive Surgical, Inc.

Reason for recall

Reports of friction within certain instrument arms can interrupt smooth instrument motion. This can be felt by the surgeon as resistance in the movement of the master.In this situation, the instrument can stall momentarily and then suddenly catch-up to the master position if the surgeon pushes through the resistance.

Action taken

The firm, Intuitive Surgical, sent an "Urgent Medical Device Recall" letter dated November 11, 2013 all affected customers via traceable mail. The letter described the product, problem and actions to be taken. The customers were instructed to take the following actions: 1. Ensure all appropriate personnel are fully informed of this Notification. Forward this letter to all Surgeons and OR staff who perform da Vinci surgical procedures, Risk Manager, OR Director, Purchasing, and Biomedical Engineering staff. 2. Complete the attached Acknowledgement Form and return it to Intuitive Surgical via Fax to: Intuitive Surgical, Inc., ATTN: REGULATORY AFFAIRS U.S. +1 (408) 716-3040, or Scan and Email: isi.compliance@intusurg.com. 3. An Intuitive Surgical Representative will contact your site to schedule the inspection of the instrument arms on your system(s) as indicated above. Please work with the Intuitive Surgical Representative to schedule this activity. 4. Please inform appropriate personnel when the correction has been completed. 5. Please retain a copy of this letter and the Acknowledgement Form for your files. If you need further information or support concerning this medical device correction, then please contact your Clinical Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below. North and South America: 800-876-1310 Option 3 (6 am to 5pm PST) Japan: 0120-56-5635 or 03-5575-1362 (9am to 6pm JST) South Korea: 02-3271-3200 (9am to 6pm KSTJ) Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET).

Root cause

Device Design

Status

Terminated

Product code

NAY

Quantity affected

1,386

Distribution

Worldwide Distribution: US (nationwide) and to countries of: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Denmark, France, Germany, India, Israel, Italy, Japan, S. Korea, Lu

Date initiated

2013-11-11

Date posted

2013-12-03

Date terminated

2014-02-18

Location

Sunnyvale, CA

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