—#176935

Product

Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-19, UDI: (00) 886874112298

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: Serial Number/Manufacturing Lot: N11181003, N11181004

Why it was recalled

This recall is being initiated because lots of EndoWrist Monopolar Curved Scissor instruments are not recognized by the integrated electrosurgical unit, which prohibits the activation of monopolar energy from the surgeon console.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

On 12/4/2018 date, the firm provided consignees a "Urgent Medical Device Recall" letter. The letter informed customers about the recall. In addition to providing information about the recall, the letter asked customers to do the following: 1.Locate and return all affected instruments in your inventory via the standard Intuitive RMA process as soon as possible. 2. Inform affected personnel when the return has been completed. 3. Please log into the da Vinci Online Community Field Action resource to read or complete any requested actions related to this issue, at this link: https://www.davincisurgerycommunity.com/ 4. In the case where the da Vinci online resource cannot be used, complete the attached Acknowledgement Form and return it via fax to Intuitive Surgical as instructed on the form. 5. Please retain a copy of this letter and the acknowledgement form for your files. 6.If you need further information or support concerning this Medical Device Recall, 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 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com.

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 1266 Kifer Rd, Bldg 101, Sunnyvale, California 94086-5304

Distribution

Distribution pattern: US National Distribution Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming OUS:None

Timeline

Recall initiated: 2018-12-04
Terminated: 2022-08-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #176935. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.