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U.S. Department of Health and Human Services

Class 2 Device Recall da Vinci X/Xi Instrument Arm Drapes

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  Class 2 Device Recall da Vinci X/Xi Instrument Arm Drapes see related information
Date Initiated by Firm September 21, 2021
Create Date November 23, 2021
Recall Status1 Terminated 3 on January 25, 2024
Recall Number Z-0275-2022
Recall Event ID 88783
510(K)Number K131861  
Product Classification System, surgical, computer controlled instrument - Product Code NAY
Product The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist 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 system and its primary function is to support the instrument arms and camera arm.
The X/Xi Instrument Arm Drape is intended to be used with the instrument arms of the PC as a sterile barrier during clinical procedures, and makes the instrument arms sterile and suitable for surgery. X/Xi Instrument Arm Drapes are sterile unless the package is opened or damaged, and are indicated for a single use. The drapes are placed onto the instrument arms by two users (one sterile and one non-sterile)in tandem, with the non-sterile user leading the placement via drape cuff pockets.
Code Information Part number: 470015-07; Lot number: DM4210309; REF: 470015; UDI # 00886874112199.
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 101
Sunnyvale CA 94086-5304
For Additional Information Contact Karen Smith
408-523-5313
Manufacturer Reason
for Recall		 Incorrect expiration date on its package labeling (shipper box and inner carton label).
FDA Determined
Cause 2		 Labeling Change Control
Action On September 21, "Urgent Medical Device Recall"-customer letter was sent out to the affected sites, via FedEx and an updated letter with legible print of labels on October 21 to non-responder customers for incorrect expiration date on the package labeling (shipper box and inner carton) label. Both shipper and carton label had expiration date as 11/30/2023 instead of 01/31/2023. The Affected product is being requested to be returned per attached field safety notice (5556010-01 Rev A). The customers had been requested to fax or E-mail the acknowledgement form to, Attn: REGULATORY COMPLIANCE FIELD ACTIONS; Subject line for email: ISIFA2021-05-R Xi Drape Expiration Date U.S. Fax +1(408) 523-0619, or Scan and Email: Recalls@intusurg.com. The firm expects customers to call or email the firm with the unused quantities to receive the replacement or credit to return the affected devices, if customers call or send an E-mail. The firm will provide RMA when customers call the firm. Customers are advised to take actions as: Inform necessary hospital personnel about this issue. 2. Locate all affected products at their site and return to the firm via the standard RMA process. 3. Inform affected personnel when the requested actions have been completed. 4. Complete the attached Acknowledgement Form immediately and return to the firm via fax or email as instructed on the form. 5. Please retain a copy of this letter and the acknowledgement form for customer's files. Replacements will be provided against returned affected product. Customers are provided contact information as: Customers Clinical Sales Representative or contact at the numbers listed below: " North America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com. " South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ)
Quantity in Commerce 1,740 drapes (87 bobes)
Distribution Worldwide distribution - U.S. Nationwide distribution in the states of AL, CA, GA, IL, FL, CO, TX, MO, OH, MA, WI, NC, LA, UT and the country of South Korea.
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.
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