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Terminated

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

FDA Recall Z-1105-2020 · Posted None

Recall StatusTerminated
Product CodeNAY
Date Initiated2018-12-04
Date Terminated2022-08-24
Product Quantity286 Monopolar curved scissors

Reason for Recall

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.

Firm 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.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: [email protected].

Root Cause

Nonconforming Material/Component

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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