BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENHANCE

    MDR report key: 16102172 · Received January 5, 2023

    Report

    Report Number
    3007593944-2022-00002
    Event Type
    Malfunction
    Date Received
    January 5, 2023
    Date of Event
    December 2, 2022
    Report Date
    February 14, 2023
    Manufacturer
    ASENSUS SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K220889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE INVESTIGATION THE SERVICE RECORDS WERE REVIEWED AND SHOWED NO ANOMALOUS FINDINGS. THE SOFTWARE TEAM CONFIRMED THAT THE FORCE LIMITATIONS ON THE SYSTEM FOLLOWED THE APPROPRIATE REQUIREMENTS SET. THE RISK OF JAW FORCE DAMAGE IS NOT NEW TO THE INDUSTRY. THE POSSIBILITY OF JAW FORCE DAMAGE TO TISSUE EXISTS JUST AS MUCH WITH A MANUAL INSTRUMENT OR EVEN WITH OTHER ROBOTIC SYSTEMS AS IT DOES WITH SENHANCE. THIS WAS DESIGNED TO PERFORM SIMILARLY TO A MANUAL INSTRUMENT ENHANCING THE FORCE MANUAL CONTROL. THUS, A SURGEON EXERTING MAXIMUM FORCE CAN CAUSE DAMAGE IN THE SAME AS WAS SEEN. AS WITH THE ESTABLISHED PRACTICE OF USING MANUAL LAPAROSCOPIC TOOLS, ONE OF THE MITIGATIONS AGAINST INJURY IS TRAINING USERS ON PROPER GRASPING TECHNIQUES DURING THE USE OF THE SYSTEM TO PREVENT THESE TYPES OF OCCURRENCES FROM HAPPENING. THE NEED FOR CAREFUL MANIPULATION OF TISSUE AND INSTRUCTION THAT THE SENHANCE SYSTEM DOES NOT PROVIDE JAW FORCE FEEDBACK IS TAUGHT IN SENHANCE TRAINING. THE SYSTEM DID NOT OPERATE OUTSIDE THE INTENDED USE AND NO MALFUNCTION HAS BEEN IDENTIFIED. THE EVENT WILL BE TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 0

    THE INSTRUMENT FUNCTIONS PROPERLY AND SAFELY, BUT FURTHER EVALUATION OF THE DEVICE SOFTWARE WILL BE PERFORMED FOR THE BIPOLAR ATRAUMATIC GRASPER, ARTICULATING (X9007672). IN GENERAL, THE SENHANCE SYSTEM USES POSITION CONTROL TO DRIVE INSTRUMENT JAW POSITION, MEANING THAT THE SYSTEM WILL ATTEMPT TO FULLY CLOSE THE JAW WHEN THE SURGEON'S HANDLES (LTM HANDLES) ARE FULLY CLOSED. THE DRIVEN POSITION OF THE JAWS AND RESULTANT EXERTION OF JAW FORCES IS DIRECTLY CONTROLLED BY THE SURGEON'S MANIPULATION OF THE LTM HANDLES. THE SURGEON IS ABLE TO CONTROL THE LTM HANDLES AND INSTRUMENT JAWS ALONG A RANGE OF POSITIONS BETWEEN OPEN AND CLOSED, AND IS NOT OBLIGATED TO OPERATE IN POSITIONS OF ONLY FULLY-OPENED OR FULLY-CLOSED. THE INSTRUMENTS ARE DESIGNED TO PERFORM SIMILARLY TO MANUAL LAPAROSCOPIC INSTRUMENTS. THE SYSTEM IS CALIBRATED TO ALLOW FOR FULL CLOSURE OF THE INSTRUMENT JAWS, WHICH MEANS THE JAW FACES CAN TOUCH EACH OTHER WHEN THE CONTROL HANDLES ARE FULLY SQUEEZED. THIS ALSO MEANS THE JAWS CAN APPLY THE FORCES INDICATED IN THE CALIBRATION WHEN FULLY CLOSED. THE MAXIMUM FORCES ARE NECESSARY FOR CERTAIN TECHNIQUES SUCH AS GRASPING A NEEDLE, BUT EXERTING MAXIMUM FORCES ON TISSUE MAY BE INAPPROPRIATE.

    Description of Event or Problem · 0

    THE EVENT OCCURED ON (B)(6) 2012 AT (B)(6) MEDICAL CENTER , WHICH IS LOCATED IN NEW JERSEY. THE EVENT WAS REPORTED TO THE COMPANY BY ASENSUS CLINICAL SALES MANAGER. THE EVENT INVOLVED THE BIPOLAR ATRAUMATIC GRASPER, ARTICULATING (X9007672). THE TIME OF OCCURANCE WAS DURING A SURGICAL CASE, WHEN MANIPULATING THE STOMACH DURING DISSECTION IN A SLEEVE GASTRECTOMY. THE PATIENT WEIGHED 242 LBS, WITH BMI OF 36.8. IT WAS REPORTED BY THE SURGEON THAT THE ARTICULATING GRASPER JAWS PRODUCED EXCESSIVE FORCE WHEN CLOSING. THE ARTICULATING INSTRUMENT EXERTED ENOUGH FORCE TO LEAVE IMPRESSIONS ON THE PATIENTS TISSUE. WHEN MANIPULATING THE STOMACH DURING DISSECTION IN A SLEEVE GASTRECTOMY, NUMEROUS JAW MARKS WERE LEFT ON THE STOMACH. THE SURGEON STATED THAT THE USER HAD TO BE VERY CAREFUL TO NOT CAUSE TRAUMATIC IMPACT TO THE STOMACH TISSUE WITH THE INSTRUMENT. THERE WAS NO CHANGE TO SURGICAL TECHNIQUE OR APPROACH DUE TO THE INJURY. NO ADDITIONAL PORTS NEEDED TO BE PLACED AS A RESULT OF THE INJURY. IT WAS NOT NECESSARY TO OPEN OR USE ADDITIONAL INSTRUMENTS OR DEVICES AS A RESULT OF THE INJURY. THE INJURY DID NOT NECESSITATE A CHANGE FROM MINIMALLY INVASIVE SURGERY TO OPEN SURGERY. THE PATIENT DID NOT EXPERIENCE A HIGHER THAN EXPECTED BLOOD LOSS DUE TO THE INJURY AND DID NOT REQUIRE INTRAOPERATIVE TRANSFUSION AS A RESULT. THE INJURY DID NOT LEAD TO A LONGER TIME UNDER ANESTHETIC OR TO ANY COMPLICATIONS RELATED TO ADDITIONAL TIME UNDER ANESTHETIC. THE PROCEDURE WAS COMPLETED WITHOUT CONVERSION WITH THE SENHANCE SYSTEM.

    Description of Event or Problem · 0

    THE EVENT OCCURED ON (B)(6) 2012 AT (B)(4) CENTER AT (B)(4), WHICH IS LOCATED IN (B)(4). THE EVENT WS REPORTED TO THE COMPANY BY ASENSUS CLINICAL SALES MANAGER. THE EVENT INVOLVED THE BIPOLAR ATRAUMATIC GRASPER, ARTICULATING (X9007672). THE TIME OF OCCURANCE WAS DURING A SURGICAL CASE, WHEN MANIPULATING THE STOMACH DURING DISSECTION IN A SLEEVE GASTRECTOMY. THE PATIENT WEIGHED 242 LBS, WITH BMI OF 36.8. IT WAS REPORTED BY THE SURGEON THAT THE ARTICULATING GRASPER JAWS PRODUCED EXCESSIVE FORCE WHEN CLOSING. THE ARTICULATING INSTRUMENT EXERTED ENOUGH FORCE TO LEAVE IMPRESSIONS ON THE PATIENTS TISSUE. WHEN MANIPULATING THE STOMACH DURING DISSECTION IN A SLEEVE GASTRECTOMY, NUMEROUS JAW MARKS WERE LEFT ON THE STOMACH. THE SURGEON STATED THAT THE USER HAD TO BE VERY CAREFUL TO NOT CAUSE TRAUMATIC IMPACT TO THE STOMACH TISSUE WITH THE INSTRUMENT. THERE WAS NO CHANGE TO SURGICAL TECHNIQUE OR APPROACH DUE TO THE INJURY. NO ADDITIONAL PORTS NEEDED TO BE PLACED AS A RESULT OF THE INJURY. IT WAS NOT NECESSARY TO OPEN OR USE ADDITIONAL INSTRUMENTS OR DEVICES AS A RESULT OF THE INJURY. THE INJURY DID NOT NECESSITATE A CHANGE FROM MINIMALLY INVASIVE SURGERY TO OPEN SURGERY. THE PATIENT DID NOT EXPERIENCE A HIGHER THAN EXPECTED BLOOD LOSS DUE TO THE INJURY AND DID NOT REQUIRE INTRAOPERATIVE TRANSFUSION AS A RESULT. THE INJURY DID NOT LEAD TO A LONGER TIME UNDER ANESTHETIC OR TO ANY COMPLICATIONS RELATED TO ADDITIONAL TIME UNDER ANESTHETIC. THE PROCEDURE WAS COMPLETED WITHOUT CONVERSION WITH THE SENHANCE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195356 SENHANCE BIPOLAR ATRAUMATIC GRASPER, ARTICULATING NAY ASENSUS SURGICAL, INC. X9007672

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other