Recall Z-1105-2020 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-19, UDI: (00) 886874112298
| Date | Dec 4, 2018 |
| Status | Terminated |
| Reason | 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 | Nonconforming Material/Component |
| Action | 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.davinc |
| Quantity | 286 Monopolar curved scissors |
| Distribution | 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, Oklah |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131861 | DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES Intuitive Surgical, Inc., Mar 28, 2014 |