Z-1819-2017 Class II Terminated
FDA device recall Z-1819-2017 was initiated by Intuitive Surgical, Inc. on March 31, 2017 and is designated Class II. Reason for recall: Intuitive Surgical has become aware that in specific scenarios with system software P6 and the da Vinci Xi Suction Irrigator (PN 480299-03), users can experience unexpected motion of a system arm. The recall status is terminated (terminated July 28, 2017). Affected quantity: 15 x 6 packs (90 units).
Recall Details
- Product Type
- Devices
- Report Date
- April 19, 2017
- Initiation Date
- March 31, 2017
- Termination Date
- July 28, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 x 6 packs (90 units)
Product Description
da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE, EMBEDDED RLS, IS4000, A70_P6_B440; PN 610092-440. General and Plastic Surgery: The EndoWrist¿ Suction Irrigator is designed to be used in conjunction with an Intuitive Surgical da Vinci Surgical System and compatible suction and irrigation sources and tubing sets for delivering fluid to the surgical site and for evacuation and aspiration of fluids. The instrument may also be used for retraction and blunt dissection of tissue. The instrument tip is blunt and intended to contact tissue.
Reason for Recall
Intuitive Surgical has become aware that in specific scenarios with system software P6 and the da Vinci Xi Suction Irrigator (PN 480299-03), users can experience unexpected motion of a system arm.
Distribution Pattern
US Only - one location each in AL, CO, KS, NV, NY, and 2 in TX
Code Information
All