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RecallWatchMedical Device Safety
Class IIOngoingZ-0923-2025

Intuitive Surgical, Inc. recalls 8MM

Intuitive Surgical, Inc.Sunnyvale, CA, United StatesReported Jan 22, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

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

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    UDI-DI code
    305 affected lots
    S10131217S10131218470207-07S10140619S10140622S10140626S10140718S10140811
    +297 moreS10140912S10141113S10141121S10150117S10150202470207-08N10160112N10160128N10160219N10160316N10160407N10160420N10160629N10160705N10160802N10160824N10160830N10160914N10160929N10161011N10161103N10161109N10161129N10161212N10170111N10170201N10170217N10170308N10170410N10170509N10170517N10170612N10170623N10170705N10170720N10170809N10170821N10170829N10170908N10170927N10171123N10171204N10180108N10180119N10180307N10180308N10180322N10180404N10180423N10180516N10180523N10180528N10180605N10180613S10141219S10150207S10150213S10150310S10150401S10150416S10150505S10150518S10150520S10150618S10150707S10150715S10150825S10150903S10150923S10151002S10160106S10160120S10160129S10160225S10160309S10160323S10160408S10160510S10160602S10160613S10160617S10160623S10160707S10160719S10160809S10160822S10170103S10170522S10170525S11150610S11150717S11150730S11150818S11151008S11151203S11151219S11160113S12150807S12150928S12151112S13151016T10170907T10170919T10171219T10180213470207-10K10210726K10210921K10210927K10211004K10211011K10211018K10211025K10211108K10211116K10211122K10211129K10211213K10211220K10220117K10220214K10220228K10220307K10220314K10220321K10220425K10220502K10220523K10220530K10220606K10220613K10220620K10220704K10220711K10220718K10220725K10220802K10220808K10220815K10220905K10220926K10221009K10221016K10221030K10221102K10221212K10221218K10230108K10230205K10230212K10230226K10230302K10230310K10230316K10230323K10230420K10230427K10230504K10230511K10230518K10230525K10230601K10230608K10230615K10230706K10230713K10230803K10230810K10230928K10231005K10231109K10231123K10231130K10240104K10240111K10240119K10240208K10240215K10240222K10240314K10240321K10240411K10240417K10240502K10240509K10240613K10240620K10240815K10240822K10240829K10240905K10240912K11211220K11221009K11230108K11230817K11230928K11231116K11231123K11240119K11240829K12231123N10180620N10180719N10180727N10180907N10181011N10181017N10181203N10181217N10181219N10181221N10190116N10190127N10190218N10190225N10190305N10190316N10190324N10190403N10190410N10190427N10190511N10190514N10190522N10190613N10190722N10190729N10190812N10190819N10190826N10190923N10191028N10191104N10191125N10191202N10200106N10200121N10200206N10200302N10200305N10200309N10200323N10200413N10200420N10200427N10200511N10200518N10200525N10200720N10200810N10200813N10200817N10200824N10200831N10200907N10200909N10200914N10200921N10200928N10201012N10201019N10201110N10201117N10201123N10201130N10201207N10201209N10210104N10210111N10210118N10210125N10210202N10210208N10210215N10210222N10210301N10210308N10210316N10210322N10210412N10210607N10210621N10210628N10210719N10210802N10210823N10210906N10210913N11200323T10180718T10181008T10200106T10200203T10200220T10200529T10200630

What the firm is doing

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)

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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