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U.S. Department of Health and Human Services

Class 2 Device Recall da Vinci Xi EndoWrist Suction Irrigator

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  Class 2 Device Recall da Vinci Xi EndoWrist Suction Irrigator see related information
Date Initiated by Firm March 31, 2017
Date Posted April 13, 2017
Recall Status1 Terminated 3 on July 28, 2017
Recall Number Z-1819-2017
Recall Event ID 76911
510(K)Number K162973  
Product Classification System,surgical,computer controlled instrument - Product Code NAY
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.
Code Information All
Recalling Firm/
Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale CA 94086-5304
For Additional Information Contact Mark Johnson
Manufacturer 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.
FDA Determined
Cause 2
Software design
Action 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.
Quantity in Commerce 15 x 6 packs (90 units)
Distribution US Only - one location each in AL, CO, KS, NV, NY, and 2 in TX
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NAY and Original Applicant = Intuitive Surgical, Inc.