—#189521

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.

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K131861
Affected lot / code info: Part number: 470015-07; Lot number: DM4210309; REF: 470015; UDI # 00886874112199.

Why it was recalled

Incorrect expiration date on its package labeling (shipper box and inner carton label).

Root cause (FDA determination)

Labeling Change Control

Action the firm took

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)

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 1266 Kifer Rd, Bldg 101, Sunnyvale, California 94086-5304

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2021-09-21
Terminated: 2024-01-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #189521. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.