BEUDAMED
    FDA Recall 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 · Initiated September 15, 2023

    Recall

    Recall Number
    Z-0170-2024
    Event Number
    93129
    Firm
    Asensus Surgical Inc
    FEI Number
    3007593944
    Product Code
    NAY
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 15, 2023
    Posted
    October 30, 2023
    Terminated
    September 26, 2024
    Address
    1 Tw Alexander Dr, Ste 160, Durham, NC, 27709

    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.

    Action

    Asensus Surgical issued an URGENT MEDICAL DEVICE RECALL to its consignees on 09/15/2023 by mail. The notice explained the problem, risk to health, and requested users to cease use of the device until software version 2.7.5 is installed.

    Distribution

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

    Quantity

    21 units