8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedure

FDA device recall Z-0923-2025 · posted 2025-01-16 · Open, Classified

Recall details

Recalling firm

Intuitive Surgical, Inc.

Reason for recall

Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments

Action taken

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)

Root cause

Device Design

Status

Open, Classified

Product code

NAY

Quantity affected

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,

Date initiated

2024-12-19

Date posted

2025-01-16

Location

Sunnyvale, CA

Related 510(k) clearances