Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Sur
Summary
The FDA issued a Class I for Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( C by Asensus Surgical Inc. Reason: Asensus Surgical has identified a malfunction that has occurred and may recur on the Senhance Surgical System. This issue presented itself as uncontro.
Details
Source
Device Recall
External ID
Z-0170-2024
Action Date
2023-11-08
Status
Terminated
Category
device
Product 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
Lot/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
Quantity Affected: 21 units
Reason for Recall
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.
Distribution
US: NJ, LA, FL, MN, IL, and Germany, Japan, Lithuania
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-15
Company
Durham, NC
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 156 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Asensus Surgical Inc has 4 FDA actions in our database, including 1 recall and 3 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Asensus Surgical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Asensus Surgical Inc have FDA actions?
Asensus Surgical Inc has 4 FDA actions in our database, including 1 recall and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0170-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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