BEUDAMED
    FDA Enforcement Class I Terminated

    Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Surgical Unit (Catalog Number X9007696), and Cockpit, ISU Configuration (Catalog Number X9007707), Software (SW) version 2.7.4; robotic surgical system

    Recall: Z-0170-2024 · Reported November 8, 2023

    Enforcement

    Recall Number
    Z-0170-2024
    Event ID
    93129
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Asensus Surgical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 8, 2023
    Initiation Date
    September 15, 2023
    Classification Date
    October 30, 2023
    Termination Date
    September 26, 2024
    Address
    1 Tw Alexander Dr Ste 160, N/A, Durham, NC, 27709, United States

    Description

    Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Surgical Unit (Catalog Number X9007696), and Cockpit, ISU Configuration (Catalog Number X9007707), Software (SW) version 2.7.4; robotic surgical system

    Reason

    Asensus Surgical has identified a malfunction that has occurred and may recur on the Senhance Surgical System. This issue presented itself as uncontrolled arm motion of the Laparoscope Instrument Actuator (LIA) where the LIA rotated continuously in one direction after the Surgeon removed the engagement of teleoperation on the Senhance System. There was no other uncontrolled arm motion observed.

    Code Info

    UDI/DI 00815440022075, Serial Numbers: SN 00012, SN 00016, SN 00007, SN 00017, SN 00035, SN 00018, SN 00042, SN 00008, SN 00031, SN 00025, SN 00011, SN 00028, SN 00038, SN 00029, SN 00036, SN 00025, SN 00024, SN 00006, SN 00019, SN 00040, SN 00041, loaded with Software (SW) version 2.7.4

    Distribution

    US: NJ, LA, FL, MN, IL, and Germany, Japan, Lithuania

    Quantity

    21 units