da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12

FDA device recall Z-2059-2023 · posted 2023-06-30 · Open, Classified

Recall details

Recalling firm

Intuitive Surgical, Inc.

Reason for recall

Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or undetected.

Action taken

On 6/12/23 Field Safety Notices were mailed and emailed to customers asking them to do the following: 1) Locate and return affected devices. 2) Notify all surgeons and users of the device about the contents of the notice. 3) Complete and return the acknowledgement form to Recalls@intusurg.com If you need further information or support concerning this Medical Device Notification, please contact your Clinical Sales Representative or contact Customer Service at: - North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com. - Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or ics@intusurg.com - South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) - Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) - India: +1-800-103-6952 (9 AM to 6 PM IT) - Taiwan: +0800-86-8181 (9 AM to 6 PM CT)

Root cause

Process control

Status

Open, Classified

Product code

NAY

Quantity affected

46,033

Distribution

Worldwide - US Nationwide distribution in the states of PR, FL, MN, PA, AZ, OH, IL, NC, GA, KS, CA, HI, MD, OR, SC, AK, NY, NE, IA, WA, OK, ND, UT, MS, AR, WI, MI, TX, TN, IN, NJ, VA, SD, CO, KY, AL,

Date initiated

2023-06-12

Date posted

2023-06-30

Location

Sunnyvale, CA

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