BEUDAMED
    FDA Enforcement Class II Terminated

    daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci Surgical System (Model IS4000) for resection, transection, and/or creation of anastomoses in General, Thoracic, Gynecologic and Urologic surgery. The device can be used with the same staple line or tissue buttressing material (natural synthetic).

    Recall: Z-0404-2018 · Reported January 31, 2018

    Enforcement

    Recall Number
    Z-0404-2018
    Event ID
    78908
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intuitive Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 31, 2018
    Initiation Date
    September 19, 2017
    Classification Date
    January 23, 2018
    Termination Date
    January 30, 2024
    Address
    1266 Kifer Rd Bldg 101, N/A, Sunnyvale, CA, 94086-5304, United States

    Description

    daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci Surgical System (Model IS4000) for resection, transection, and/or creation of anastomoses in General, Thoracic, Gynecologic and Urologic surgery. The device can be used with the same staple line or tissue buttressing material (natural synthetic).

    Reason

    Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in the manufacturing process. In affected instruments, there is a possibility that the Stapler Release Kit (SRK) Wrench interface feature accessed through release hole 2 is manufactured to an incorrect dimension, which may prevent the SRK Wrench from being able to manually unclamp the instrument.

    Code Info

    UDI 00886874112427: Serial Numbers: S10170630, S11170705, S10170707, S10170731

    Distribution

    US Nationwide Distribution

    Quantity

    60 units