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AnovoTM Instrument ARMS -Recalls & reported problems

Momentis Surgical Ltd · The Anovo Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic manipulation of tissue, using graspers and electrosurgery devices during single-site laparoscopic gynecologic procedures such as benign hysterectomy and salpingo-oophorectomy through a transvaginal access point. The system composed of Anovo Surgeon Console, two sterile instruments (Anovo Instrument ARMS), bed-mounted Robotic Control Unit (RCU) and Anovo System Accessories (Unit cables, Sterile Drapes, Robotic Control Unit Support System (RCUSS) and Vaginal Access Kit). The Anovo Instrument ARMS are the system’s components that are inserted transvaginally into the pelvic cavity to manipulate the tissue and perform the surgery. Two identical Instrument ARMS are connected to the Robotic Control Units, each of which corresponds to the respective hand of the surgeon as controlled by right or left Controllers. The two Arms utilized with the Anovo System are identical and provide identical capabilities. The end effector, located at the end of the flexible section, provides grasping and electrosurgical capabilities. The Instrument Arm is a sterile disposable component. It is ETO sterilized and provided to the user within a plastic tray packaged in a sterile pouch. Instrument ARMS Packed with Cannula Seal & ARMS Entry Guide Seal · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 17290018151096), received between Mar 2, 2022 and Mar 2, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Mechanical Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 2, 2022Mechanical Problem; Mechanical Problem

    THE EVENT WAS A MALFUNCTION AND NOT SAFETY RELATED. DURING THE PROCEDURE, ONE OF THE JOINTS (SHOULDER) OF ONE OF THE ROBOTIC ARMS COULD NOT BE STRAIGHTENED. FOLLOWING A FEW ATTEMPTS, STRAIGHTENING USING THE MANUAL RELEASE TOOL (MRT) WAS ATTEMPTED BUT THE JOINT DID NOT RESPOND. THE SURGEON THEN DECIDED TO FOLLOW AN ALTERNATIVE ROUTE OF DISCONNECTING THE ARMS FROM THE ROBOTIC CONTROL UNIT (RCU) AND SUCCESSFULLY REMOVED THE ARM SAFELY THROUGH THE RIGID METALLIC CANNULA. BY DESIGN, THE ARM CAN BE REMOVED THROUGH THE CANNULA EVEN IF IT IS NOT STRAIGHT SINCE THE ARM IS PLIABLE AND WILL STRAIGHTEN DURING ITS EXTRACTION THROUGH THE CANNULA. THIS MALFUNCTION IS ASSESSED TO BE A FUNCTIONAL ISSUE AND NOT SAFETY RELATED. NO HARM OR INJURY TO THE PATIENT WAS REPORTED. A HEALTH HAZARD ANALYSIS WAS PERFORMED WITH RESPONSIBLE CLINICIANS. IT WAS ASSESSED THAT IF THE MALFUNCTION WERE TO RECUR IT IS NOT LIKELY TO RESULT IN DEATH OR SERIOUS INJURY. THE MDR IS REPORTED IN ABUNDANCE OF CAUTION AS THE "BY DESIGN" MITIGATION FOR THE PRODUCT PROBLEM LISTED IN THE RISK ANALYSIS FILE DID NOT PERFORM IN A SATISFACTORY WAY, AS EXPECTED BY THE USER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13646967 ↗

Sources and updates

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