—#154548

Product

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.

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K162973
Affected lot / code info: All

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

Firm sent e-mails on 3-17-17 to affected sites instructing them to STOP USE of the XI Suction Irrigator and RMA. and return all unused Xi Suction/irrigation instruments for credit. A formal letters was sent to affected sites on March 31, 2017. Letters advised of the reason for recall with details on product name and product number. Letters requested that any unused devices be returned to Intuitive via the standard RMA process. All personnel who use the Da Vinci system should be made aware of the issue. Response form should be completed online or by returning copy enclosed with the letter.

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 1266 Kifer Rd, Bldg 100, Sunnyvale, California 94086-5304

Distribution

Distribution pattern: US Only - one location each in AL, CO, KS, NV, NY, and 2 in TX

Timeline

Recall initiated: 2017-03-31
Posted by FDA: 2017-04-13
Terminated: 2017-07-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #154548. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.