Class 2 Device Recall 8MM, Small Graptor

• Date Initiated by Firm: December 19, 2024
• Date Posted: January 16, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0924-2025
• Recall Event ID: 95939
• 510(K)Number: K131861
• Product Classification: System, surgical, computer controlled instrument - Product Code NAY
• Product: 8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.
• Code Information: Product Number: 470318 UDI-Di code: 00886874112441 Part Number and Version: 470318-04 Lot Numbers: S10131209 S10131210 Part Number and Version: 470318-07 Lot Numbers: S10140617 S10140618 S10140619 S10140620 S10140717 S10140801 S10140812 S10140821 S10140823 S10140915 S10141008 S10141120 S10141205 S10141219 S10150108 S10150120 S10150122 S10150206 S10150212 S11140620 Part Number and Version: 470318-08 Lot Numbers: N10151230 N10160104 N10160113 N10160203 N10160218 N10160219 N10160307 N10160317 N10160330 N10160404 N10160406 N10160420 N10160426 N10160525 N10160607 N10160616 N10160725 N10160726 N10160802 N10160810 N10160824 N10160901 N10160914 N10160927 N10161010 N10161020 N10161102 N10161111 N10161128 N10161209 N10170119 N10170203 N10170222 N10170309 N10170330 N10170419 N10170502 N10170512 N10170518 N10170612 N10170623 N10170703 N10170725 N10170728 N10170801 N10170802 N10170822 N10170823 N10170906 N10170914 N10171012 N10171101 N10171115 N10171124 N10171206 N10171219 N10171227 N10180122 N10180131 N10180209 N10180221 N10180228 N10180312 N10180328 N10180410 N10180413 N10180511 N10180518 N10180606 N10180612 N10180613 N11170725 N11170728 N12170725 S10141211 S10150223 S10150312 S10150326 S10150408 S10150417 S10150430 S10150506 S10150611 S10150706 S10150717 S10150801 S10150827 S10150914 S10151007 S10151012 S10151028 S10151104 S10151215 S10160125 S10160217 S10160413 S10160512 S10160614 S10160622 S10160715 S10160719 S10160913 S10161221 S10170525 S10170710 S11150511 S11150603 S11150624 S11150728 S11150813 S11150904 S11150926 S11151023 S11151119 S11151201 S11151231 S12150819 S12150918 S12151001 S12151008 S12151019 S12151219 S13150820 T10170822 T10170929 T10171004 T10171030 T10171127 Part Number and Version: 470318-10 Lot Numbers: K10210921 K10210927 K10211004 K10211011 K10211018 K10211103 K10211108 K10211116 K10211117 K10211122 K10211206 K10211213 K10220217 K10220221 K10220228 K10220307 K10220314 K10220404 K10220425 K10220511 K10220516 K10220613 K10220725 K10220802 K10220808 K10220815 K10220912 K10220926 K10221016 K10221030 K10221102 K10221106 K10221113 K10221117 K10221118 K10230212 K10230219 K10230226 K10230420 K10230504 K10230511 K10230518 K10230525 K10230601 K10230608 K10230615 K10230706 K10230713 K10230803 K10230817 K10230831 K10230907 K10230914 K10230921 K10230928 K10231012 K10231019 K10231027 K10231130 K10231207 K10240104 K10240116 K10240125 K10240222 K10240327 K10240404 K10240516 K10240523 K10240606 K10240711 K10240725 K10240822 K10240829 K10240905 K11211103 K11220110 K11220228 K11220511 K11220516 K11220912 K11220926 K11221030 K11230608 K12220511 K12221102 N10180620 N10180704 N10180711 N10180719 N10180823 N10180828 N10180831 N10180920 N10181001 N10181017 N10181022 N10181102 N10181106 N10181113 N10181115 N10181123 N10181128 N10181203 N10181206 N10181210 N10190103 N10190107 N10190129 N10190206 N10190211 N10190216 N10190222 N10190223 N10190226 N10190304 N10190307 N10190310 N10190322 N10190330 N10190407 N10190411 N10190425 N10190507 N10190515 N10190519 N10190521 N10190531 N10190602 N10190701 N10190715 N10190722 N10190729 N10190812 N10190819 N10190826 N10190902 N10190909 N10190917 N10190923 N10190930 N10191007 N10191028 N10191104 N10191125 N10191202 N10200106 N10200211 N10200302 N10200309 N10200317 N10200323 N10200330 N10200406 N10200413 N10200420 N10200427 N10200504 N10200629 N10200713 N10200727 N10200803 N10200810 N10200817 N10200928 N10201012 N10201019 N10201027 N10201110 N10201117 N10201123 N10201130 N10201207 N10201214 N10210104 N10210111 N10210118 N10210125 N10210202 N10210208 N10210215 N10210222 N10210301 N10210308 N10210316 N10210322 N10210405 N10210412 N10210503 N10210518 N10210531 N10210607 N10210621 N10210705 N10210719 N10210831 N10210906 N10210913 N11200323 N11200727 N11210503 N13210831 U10210805 U10220209 U10220301 U10220328 U10220506
• Recalling Firm/ Manufacturer: Intuitive Surgical, Inc.; 1266 Kifer Rd; Sunnyvale CA 94086-5304
• For Additional Information Contact: Shahbaz Khan; 408-523-2443
• Manufacturer Reason for Recall: Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
• FDA Determined Cause: Device Design
• Action: On 12/19/2024, the firm sent an "Field Safety Notice Urgent Medical Device Notification" via FedEx (US), email/hand-delivery (OUS), informing customers that Intuitive Surgical has observed an increase in complaints regarding pitch cable failure on the Tenaculum Forceps and Small Graptor retractor devices. A failure of the pitch cable can be fraying or complete break. Customers are instructed: 1. As a reminder, when using the Tenaculum Forceps and the Small Graptor instruments, refer to and follow the instructions, warnings and cautions provided in the General Overview and EndoWrist Instrument chapters of the da Vinci X/Xi Instruments and Accessories User Manual and Reprocessing Instructions User Manual. 2. Display this communication with affected systems; ensures it is in a place likely to be seen/viewed by operators. 3. Complete the Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. 4. Retain a copy of this letter and the acknowledgement form for your files. 5. Inform Intuitive of any Adverse Events*/Serious Incidents** or quality problems concerning the use of the subject devices via the standard complaint process. For questions/information/further support - contact Clinical Sales Representative or Customer Service: "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 eucs@intusurg.com "South Korea: 02-3271-3200 (9 am to 6 pm KSTJ) or support.korea@intusurg.com "Japan: 0120-56-5635 or 03-5575-1362 (9 am to 6 pm JST) or csjapan@intusurg.com "India: +1-800-103-6952 (9 am to 6 pm IT) "Taiwan: +0800-86-8181 (9 am to 6 pm CT)
• Quantity in Commerce: 42028 devices
• Distribution: U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WI, and WY. The countries of Canada, Austria, Belgium, Denmark, Finland, France, French Guiana, Germany, Guadeloupe, Ireland, Luxembourg, Martinique, Monaco, Netherlands, Norway, Reunion, Sweden, Switzerland, United Kingdom, India, Japan, South Korea, Taiwan, Brazil, Argentina, Australia, Bulgaria, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Ecuador, Greece, Hong Kong, Hungary, Iceland, Israel, Italy, Kuwait, Lebanon, Malaysia, Malta, Mexico, New Zealand, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Thailand, Turkey, United Arab Emirates, Venezuela, Vietnam.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NAY