medical Class II Updated 2020-05-13

Intuitive Surgical Inc recalls da Vinci X Surgical System, IS4200 - Product Usage: The da V

Recalled Product

da Vinci X Surgical System, IS4200 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the IS4000 system and its primary function is to support the instrument arms and camera arm. The system has four Universal Surgical Manipulators (USM) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. There are four USM per da Vinci X surgical system.


Hazard / Issue

Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm movement to include: feelings of resistance, hesitation, and jerking.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: 00886874114216 Device Listing: D295931 Serial Numbers: SL0085, SL0315, SL0317, SL0324, SL0338, SL0350, SL0351, SL0353, SL0354, SL0357, SL0369
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