Senhance X9007708Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815440022075), received between Sep 15, 2023 and Sep 15, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (1 report).

1 FDA recall record name this device's identifier.

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 16, 2026.

Recalls naming this device

1. Sep 15, 2023Terminated

   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.

   Z-0170-2024 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionSep 15, 2023Unintended System Motion; Unintended Movement; Unintended System Motion; Unintended Movement

  THIS EVENT WAS MADE AWARE TO ASENSUS SURGICAL ON (B)(6) 2023. THIS EVENT OCCURRED AT (B)(6) HOSPITAL IN (B)(6), JAPAN. AS INITIALLY REPORTED BY THE COMPLAINANT, ON (B)(6) 2023, THE CLINICAL SPECIALIST NOTICED A MESSAGE ON THE COCKPIT MONITOR APPLICABLE TO THE GREEN ARM STATUS ICON STATING "NOT AVAILABLE." THE ATTACHED MONOPOLAR SCISSORS ON THE GREEN ARM BEGAN TO ROTATE WITHOUT OPERATOR INPUT. THE SURGEON HAD NOT YET GRASPED TISSUE AND THERE WAS NO HARM TO THE PATIENT. THE GREEN ARM WAS REPLACED WITH A PINK ARM, AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUES UPON THE ARM EXCHANGE. THE TOTAL DELAY TO THE PROCEDURE WAS 15-30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17756783 ↗