Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-1105-2020

December 04, 2018

Class II

Product summary

Firm
Intuitive Surgical, Inc.
Event
Event 83994
Status
Terminated
Classification
Class II
Quantity
286 Monopolar curved scissors
Official record key
device-enforcement:Z-1105-2020

Official wording

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.

Code information: Serial Number/Manufacturing Lot: N11181003, N11181004

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.