Recalls / —

—#175509

Product

da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch

FDA product code

NAY — System, Surgical, Computer Controlled Instrument

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K173906

Affected lot / code info

Model Number: 430013-12 UDI Number: 00886874113486 Lot Numbers: All Lots

Why it was recalled

The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.

Root cause (FDA determination)

Device Design

Action the firm took

On 10/25/2018, the firm sent an "Urgent Medical Device Correction" Notification Letter to Customers via FedEx (to OUS customers - emailed and hand-delivered) are asked to take actions during draping to avoid snagging the drape during installation and to continue following the instructions in the System User Manual. Representatives will be available by phone to answer questions related to the device correction. Acknowledgement form included with the recall letter is requested to be completed and returned to ISI asking that appropriate personnel be informed about the device correction.

Recalling firm

Firm

Intuitive Surgical, Inc.

Address

1266 Kifer Rd, Bldg 101, Sunnyvale, California 94086-5304

Distribution

Distribution pattern

Updated information provided on 03/18/2020: FL, OH, TN, NJ, PA, MD, NY, CA, MN, NV, OR, HI, VA, TX, AL, CA, IL, CN, and NC. OUS: APAC (Asia Pacific) - South Korea

Timeline

Recall initiated

2018-10-25

Terminated

2024-04-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #175509. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.