FDA-Device2023-11-08Class I
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
Asensus Surgical Inc
Hazard
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.
Sold states
US: NJ, LA, FL, MN, IL, and Germany, Japan, Lithuania
Affected count
21 units
Manufactured in
1 Tw Alexander Dr Ste 160, N/A, Durham, NC, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0170-2024Don't want to check this manually?
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