Recall Z-0924-2025 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
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.
| Date | Jan 16, 2025 (initiated Dec 19, 2024) |
| Status | Open, Classified |
| Reason | Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments |
| Root 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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131861 | DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES Intuitive Surgical, Inc., Mar 28, 2014 |