BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENHANCE

    MDR report key: 17756783 · Received September 15, 2023

    Report

    Report Number
    3007593944-2023-00013
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    September 7, 2023
    Report Date
    October 4, 2023
    Manufacturer
    ASENSUS SURGICAL, INC.
    Product Code
    NAY
    UDI-DI
    00815440022075
    PMA / PMN Number
    K171120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE COMPLAINT DETAILS, NO ADVERSE EVENT OCCURRED TO A PATIENT OR USER. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THIS EVENT OCCURRED IN (B)(6) JAPAN. THERE WAS NO IMPACT TO THE ADULT PATIENT, AND THERE WAS A DELAY OF <30 MINUTES TO THE LAPAROSCOPIC SACROCOLPOPEXY (LSC) SURGICAL CASE WHICH IS ACCEPTABLE FOR ADULT PATIENTS ACCORDING TO THE DEVICE RISK DOCUMENTATION. THE EVENT OCCURRED ON (B)(6) 2023 INDICATING UNINTENDED LIA MOVEMENT FROM THE SITE'S GREEN MANIPULATOR ARM, AND ASENSUS SURGICAL WAS ALSO MADE AWARE ON 09/07/2023. AS REPORTED BY THE CLINICAL SPECIALIST, THE POWER SWITCH ON THE ARM WAS PRESSED TO POWER OFF THE AFFECTED MANIPULATOR ARM (GREEN ARM), THEN REPLACED WITH A SEPARATE MANIPULATOR ARM (PINK ARM) AT THE TIME OF THE EVENT. MOREOVER, THERE WAS NO HARM TO THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH NO ISSUES AFTER REPLACEMENT OF THE AFFECTED ARM. ACCORDING TO THE INTERNAL INVESTIGATION, THE ROOT CAUSE OF THE ISSUE WAS IDENTIFIED TO BE A HARDWARE FAILURE OF THE J6 DRIVER, WHICH LEADS TO A COMMUNICATION ISOLATION OF THE DRIVER, WHICH COULD NOT BE CONTROLLED VIA SW. THE INPUT CURRENT REACHING THE DRIVER LED TO THE CONTINUOUS ROTATION OF THE LIA. THE R&D SW AND SERVICE TEAM WAS ABLE TO REPRODUCE THE ISSUE BY ISOLATING ONE OR MORE MOTOR DRIVES (DISCONNECTING IN AND OUT SYNQNET CABLES). SINCE THE EVENT COULD POTENTIALLY HAVE A PATIENT IMPACT, A HEALTH HAZARD EVALUATION (RECORDED AS HHE-001-00024) HAS BEEN CONDUCTED. IT CONCLUDED THAT THE POTENTIAL SEVERITY IS A HARM OF A "CRITICAL" LEVEL, THE PROBABILITY OF OCCURRENCE IS "REMOTE", AND THE HEALTH RISK IS "MODERATE". THIS RISK HAS BEEN CONSIDERED UNACCEPTABLE TO ASENSUS SURGICAL, THUS, ACTION HAS BEEN TAKEN TO ADDRESS THIS ISSUE IN AN URGENT MANNER: A CORRECTIVE AND PREVENTIVE ACTION AND A FIELD SAFETY CORRECTIVE ACTION HAVE BEEN OPENED (SEE CAPA-000049 AND FSCA-2023-000001, LINKED IN SECTION 3 - MEDICAL DEVICE INITIAL ASSESSMENT EU). THE RESOLUTION HAS BEEN IMPLEMENTED VIA SW UPDATE, AUTOMATICALLY TRIGGERING A POWER CUT BY MEANS OF DEACTIVATING THE RELAY R34 (REPRODUCING THE EMERGENCY BUTTON TRIGGER) WHEN SYNQNET CABLES MALFUNCTION IS IDENTIFIED. THIS IMPLEMENTATION IS SUFFICIENT TO STOP THE ARM MOVEMENT AS NO ELECTRIC POWER CAN REACHING THE MANIPULATOR ARM, TRIGGERING A SERVICE STATE THAT WILL FORCE THE USER TO REBOOT THE ARM. THE SYSTEM HAS BEEN UPGRADED TO 2.7.5.17 SW VERSION ACCORDING TO THE WORK ORDER, (B)(4). ALTHOUGH THIS EVENT CAUSED NO IMPACT TO THE PATIENT IN THIS INSTANCE, THE REPORTED MALFUNCTION COULD POTENTIALLY CAUSE SERIOUS INJURY IF IT TO RECUR WHILE THE USER IS GRASPING TISSUE. THUS, THE DECISION IS TO REPORT THIS EVENT.

    Description of Event or Problem · 0

    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.

    Description of Event or Problem · 0

    THIS EVENT WAS MADE AWARE TO ASENSUS SURGICAL ON 09/07/2023. THIS EVENT OCCURRED AT (B)(6) JAPAN. AS INITIALLY REPORTED BY THE COMPLAINANT, ON 09/07/2023, 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295815 SENHANCE X9007708 - MANIPULATOR ARM ISU CONFIGURATION NAY ASENSUS SURGICAL, INC. X9007708 00815440022075

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown