Senhance X9007707Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815440022082), received between Feb 22, 2022 and Jan 16, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2024Unintended System Motion; Unintended Movement; Unintended System Motion; Unintended Movement

  BASED ON THE COMPLAINT DETAILS, NO ADVERSE EVENT OCCURRED TO A PATIENT OR USER. THE EVENT OCCURRED ON 27-DEC-2023, AND ASENSUS SURGICAL WAS ALSO MADE AWARE ON 27-DEC-2023. THIS EVENT DID NOT OCCUR IN THE UNITED STATES. THE EVENT OCCURRED AT (B)(6) HOSPITAL IN JAPAN. THERE WAS A <15 MINUTE DELAY TO THE SURGICAL CASE WHICH IS ACCEPTABLE IN THE DEVICE RISK DOCUMENTATION. THERE WAS NO IMPACT TO THE PATIENT, AND THE SURGEON CONVERTED TO TRADITIONAL LAPAROSCOPY TO COMPLETE THE CASE. THE EVENT INFORMATION STATES THAT THE SURGEON "STOPPED USING THE ULTRASONIC [DISSECTOR] BECAUSE IT MOVED IN AN UNINTENDED DIRECTION." THE CASE ASSISTANT RESET THE FULCRUM SEVERAL TIMES WITH NO IMPROVEMENT. ADDITIONALLY, THE COMPLAINANT NOTED THAT THE LEFT HANDLE INSTRUMENT (BIPOLAR CURVED GRASPER) ALSO MOVED IN A STRANGE WAY. THESE SYMPTOMS WERE DETAILED TO BE LINEAR MOVEMENTS, IN WHICH INSTRUMENTS MOVED FROM FRONT-TO-BACK. THE CLINICAL SPECIALIST ALSO CONFIRMED THAT ALL MOVEMENT STOPPED WHEN THE SURGEON RELEASED THE CLUTCH PEDAL, AND NO PARTICULAR DELAYS WERE OBSERVED FROM THE USER INPUT COMMAND (HANDLES) TO THE ACTUAL MOVEMENT OF INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519561 ↗
• MalfunctionFeb 22, 2022Unintended Movement; Unintended Movement

  THE EVENT OCCURRED ON (B)(6) 2022 AT (B)(6) HOSPITAL LOCATED IN (B)(6). THE EVENT WAS REPORTED TO THE COMPANY BY THE ASENSUS SURGICAL FIELD SERVICE ENGINEER. THE EVENT INVOLVED X9007707 SENHANCE COCKPIT (ISU CONFIGURATION) AND X9007708 SENHANCE MANIPULATOR ARM (ISU CONFIGURATION). IT WAS REPORTED THAT DURING THE SURGICAL CASE, RIGHT INGUINAL HERNIA REPAIR, THE SENHANCE MANIPULATOR ARM ASSIGNED TO THE LEFT TELEOPERATION HANDLE OF THE SENHANCE COCKPIT STARTED TO ROTATE UNEXPECTEDLY. AFTER THE SURGEON RELEASED THE FOOT PEDAL, THE MANIPULATOR ARM [LIA] STOPPED ROTATING AND WHEN THE FOOT PEDAL WAS PRESSED AGAIN, THE MANIPULATOR ARM [LIA] STARTED TO ROTATE AGAIN. THERE WAS NO INJURY TO THE PATIENT. THE SURGICAL PROCEDURE WAS COMPLETED BY TRADITIONAL LAPAROSCOPY. THE INSTRUMENT INTERFACE/LIA (LAPASCOPIC INSTRUMENT ACTUATOR) IS THE PART OF THE MANIPULATOR ARM WHERE THE INSTRUMENT ATTACHES TO THE ARM. WHILE PERFORMING TROUBLESHOOTING ACTIVITIES, THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THAT A METAL CABLE WAS OUT OF PLACE IN THE LAPAROSCOPIC TELEOPERATION MASTERS (LTM) ASSEMBLY. IN PARTICULAR, THE CABLE AROUND THE ROLL ENCODER APPEARED TO BE LOOSE. THE INVESTIGATION CONCLUDED THAT THE ROO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13577408 ↗