BEUDAMED
    FDA Enforcement Class II Ongoing

    Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098

    Recall: Z-1518-2024 · Reported April 17, 2024

    Enforcement

    Recall Number
    Z-1518-2024
    Event ID
    94252
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Intuitive Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 17, 2024
    Initiation Date
    March 13, 2024
    Classification Date
    April 11, 2024
    Address
    1266 Kifer Rd, N/A, Sunnyvale, CA, 94086-5304, United States

    Description

    Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098

    Reason

    Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal tissue injuries, body wall injury or emergent conversion to open surgery, 2) Bottom failure: pinching injury to the user with no harm to the patient.

    Code Info

    Part/UDI-DI: 380601/00886874114605. SP1098 Serial Numbers: SP0202, SP0253, SP0254, SP0219, SP0228, SP0231, SP0238, SP0273, SP0208, SP0226, SP0240, SP0247, SP0249, SP0256, SP0257, SP0268, SP0270, SP0272, SP0221, SP0223, SP0225, SP0229, SP0230, SP0232, SP0233, SP0235, SP0236, SP0237, SP0239, SP0241, SP0242, SP0243, SP0244, SP0245, SP0248, SP0250, SP0251, SP0252, SP0255, SP0258, SP0259, SP0260, SP0261, SP0262, SP0263, SP0264, SP0265, SP0266, SP0269, SP0274, SP0278, SP0280, SP0282

    Distribution

    US: VA, CA, NH, FL, NY, CO, AL, KY, MD, NC, NJ, OH, SC, SD, TN, WA, WI, WV, MS, TX, KS. OUS: China, France, Japan, South Korea

    Quantity

    53