Class 2 Device Recall 8MM, Tenaculum Forceps

• Date Initiated by Firm: December 19, 2024
• Date Posted: January 16, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0923-2025
• Recall Event ID: 95939
• 510(K)Number: K131861
• Product Classification: System, surgical, computer controlled instrument - Product Code NAY
• Product: 8MM, Tenaculum Forceps REF 470207 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: 470207 UDI-Di code: 00886874112366 Part Number and Version: 470207-04 Lot Numbers: S10131217 S10131218 Part Number and Version: 470207-07 Lot Numbers: S10140619 S10140622 S10140626 S10140718 S10140811 S10140912 S10141113 S10141121 S10150117 S10150202 Part Number and Version: 470207-08 Lot Numbers: N10160112 N10160128 N10160219 N10160316 N10160407 N10160420 N10160629 N10160705 N10160802 N10160824 N10160830 N10160914 N10160929 N10161011 N10161103 N10161109 N10161129 N10161212 N10170111 N10170201 N10170217 N10170308 N10170410 N10170509 N10170517 N10170612 N10170623 N10170705 N10170720 N10170809 N10170821 N10170829 N10170908 N10170927 N10171123 N10171204 N10180108 N10180119 N10180307 N10180308 N10180322 N10180404 N10180423 N10180516 N10180523 N10180528 N10180605 N10180613 S10141219 S10150207 S10150213 S10150310 S10150401 S10150416 S10150505 S10150518 S10150520 S10150618 S10150707 S10150715 S10150825 S10150903 S10150923 S10151002 S10160106 S10160120 S10160129 S10160225 S10160309 S10160323 S10160408 S10160510 S10160602 S10160613 S10160617 S10160623 S10160707 S10160719 S10160809 S10160822 S10170103 S10170522 S10170525 S11150610 S11150717 S11150730 S11150818 S11151008 S11151203 S11151219 S11160113 S12150807 S12150928 S12151112 S13151016 T10170907 T10170919 T10171219 T10180213 Part Number and Version: 470207-10 Lot Numbers: K10210726 K10210921 K10210927 K10211004 K10211011 K10211018 K10211025 K10211108 K10211116 K10211122 K10211129 K10211213 K10211220 K10220117 K10220214 K10220228 K10220307 K10220314 K10220321 K10220425 K10220502 K10220523 K10220530 K10220606 K10220613 K10220620 K10220704 K10220711 K10220718 K10220725 K10220802 K10220808 K10220815 K10220905 K10220926 K10221009 K10221016 K10221030 K10221102 K10221212 K10221218 K10230108 K10230205 K10230212 K10230226 K10230302 K10230310 K10230316 K10230323 K10230420 K10230427 K10230504 K10230511 K10230518 K10230525 K10230601 K10230608 K10230615 K10230706 K10230713 K10230803 K10230810 K10230928 K10231005 K10231109 K10231123 K10231130 K10240104 K10240111 K10240119 K10240208 K10240215 K10240222 K10240314 K10240321 K10240411 K10240417 K10240502 K10240509 K10240613 K10240620 K10240815 K10240822 K10240829 K10240905 K10240912 K11211220 K11221009 K11230108 K11230817 K11230928 K11231116 K11231123 K11240119 K11240829 K12231123 N10180620 N10180719 N10180727 N10180907 N10181011 N10181017 N10181203 N10181217 N10181219 N10181221 N10190116 N10190127 N10190218 N10190225 N10190305 N10190316 N10190324 N10190403 N10190410 N10190427 N10190511 N10190514 N10190522 N10190613 N10190722 N10190729 N10190812 N10190819 N10190826 N10190923 N10191028 N10191104 N10191125 N10191202 N10200106 N10200121 N10200206 N10200302 N10200305 N10200309 N10200323 N10200413 N10200420 N10200427 N10200511 N10200518 N10200525 N10200720 N10200810 N10200813 N10200817 N10200824 N10200831 N10200907 N10200909 N10200914 N10200921 N10200928 N10201012 N10201019 N10201110 N10201117 N10201123 N10201130 N10201207 N10201209 N10210104 N10210111 N10210118 N10210125 N10210202 N10210208 N10210215 N10210222 N10210301 N10210308 N10210316 N10210322 N10210412 N10210607 N10210621 N10210628 N10210719 N10210802 N10210823 N10210906 N10210913 N11200323 T10180718 T10181008 T10200106 T10200203 T10200220 T10200529 T10200630
• 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: 33,219
• 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