BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXUS® ULTRASONIC SURGICAL ASPIRATOR SYSTEM

    MDR report key: 18278683 · Received December 6, 2023

    Report

    Report Number
    2435119-2023-00021
    Event Type
    Malfunction
    Date Received
    December 6, 2023
    Date of Event
    November 3, 2023
    Report Date
    December 6, 2023
    Manufacturer
    MISONIX, INC.
    Product Code
    LFL
    PMA / PMN Number
    K231117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON NOVEMBER 06, 2023, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A PRODUCT OCCURRENCE REPORT FOR AN EVENT THAT OCCURRED ON NOVEMBER 03, 2023, WHILE USING A NEXUS® CONSOLE (P/N: 100-10-0000, S/N: (B)(6)). SPECIFICALLY, IT WAS REPORTED THE CONSOLE DISPLAYED A VACUUM FAULT MESSAGE DURING THE SURGICAL PROCEDURE. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED; HOWEVER, ON (B)(6), 2023, MISONIX RECEIVED CONFIRMATION OF A DELAY IN TREATMENT GREATER THAN 15 MINUTES. THE MISONIX REPRESENTATIVE CONFIRMED THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE IN THE SCHEDULED TIMEFRAME AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DURING THE DELAY TO TREATMENT. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE NEXUS® CONSOLE, PART NUMBER 100-10-0000, SERIAL NUMBER (B)(6). THERE WERE NO DEVIATIONS FOUND DURING IN-PROCESS OR FINAL INSPECTION OF THE DEVICE. INSPECTION AND TEST RESULTS MET SPECIFICATIONS PRIOR TO RELEASE TO COMMERCE. THE SUBJECT CONSOLE WAS RETURNED TO MISONIX FOR EVALUATION. INSPECTION AND TESTING CONCLUDED THE CONSOLE CONFORMED TO SPECIFICATIONS. NO MALFUNCTIONS THAT WOULD CAUSE OR CONTRIBUTE TO A VACUUM FAULT WERE NOTED. THE CONSOLE EXHIBITED NORMAL OPERATION AND FUNCTION. THE CURRENT FREQUENCY OF OCCURRENCE IS WITHIN THE FREQUENCY ORIGINALLY ESTIMATED IN THE ORIGINAL RISK MANAGEMENT REPORT. THEREFORE, THERE IS NO CHANGE TO THE RESIDUAL RISK OR RISK-BENEFIT RATIO. THE INVESTIGATION HAS BEEN CONCLUDED. THE INSTRUCTIONS FOR USE MANUAL (100-10-1000, REVISION J) (IFU) FOR THE NEXUS® ULTRASONIC SURGICAL ASPIRATION SYSTEM CONTAINS THE FOLLOWING WARNINGS AND CAUTIONS IN THE EVENT OF A VACUUM FAULT/NOTIFICATION: WARNING THE NEXUS® ULTRASONIC SURGICAL ASPIRATOR SYSTEM IS INTENDED TO BE USED IN VARIOUS TYPES OF INVASIVE, SURGICAL PROCEDURES. THERE MAY BE INDIRECT DANGER TO THE PATIENT SHOULD THE DEVICE FAIL DURING THE PROCEDURE. IT IS RECOMMENDED THAT THE FACILITY FOLLOWS ITS BACK-UP EQUIPMENT PROTOCOLS. CAUTION THE SYSTEM CHECK SHOULD ALWAYS BE DONE IN ADVANCE OF PREPARING PATIENT FOR SURGERY TO MINIMIZE RISK TO PATIENT IN CASE OF SYSTEM MALFUNCTION. THE NEXUS® CONSOLE AUTOMATICALLY CONDUCTS A DIAGNOSTIC SELF-TEST UPON POWER UP. THE SYSTEM PROVIDES BOTH VISUAL AND AUDIBLE ALERT SIGNALS WHEN THE SYSTEM IS NOT FUNCTIONING PROPERLY. THE FAULT SYSTEM CAN EITHER ISSUE A "NOTIFICATION" WHICH ALLOWS FOR CORRECTION AND DISMISSAL, OR A "SYSTEM RESET" MESSAGE WHICH REQUIRES A SYSTEM REBOOT AS DESCRIBED IN SECTION 9: FAULTS, INDICATORS & TROUBLESHOOTING OF THE IFU FOR THE NEXUS® ULTRASONIC SURGICAL ASPIRATION SYSTEM. SECTION 9.8 OF THE IFU STATES THAT "THE CONSOLE HAS THE ABILITY TO MONITOR CERTAIN PARTS OF THE VACUUM SYSTEM. A VACUUM FAULT CAN EITHER RESULT IN A NOTIFICATION OR A SYSTEM RESET" AND SYSTEM FUNCTIONS ARE DISABLED UNTIL THE MESSAGE IS CLEARED.

    Description of Event or Problem · 0

    ON NOVEMBER 06, 2023, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A PRODUCT OCCURRENCE REPORT FOR AN EVENT THAT OCCURRED ON NOVEMBER 03, 2023, WHILE USING A NEXUS® CONSOLE (P/N: 100-10-0000, S/N: (B)(6)). SPECIFICALLY, IT WAS REPORTED THE CONSOLE DISPLAYED A VACUUM FAULT MESSAGE DURING THE SURGICAL PROCEDURE. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED; HOWEVER, ON (B)(6), 2023, MISONIX RECEIVED CONFIRMATION OF A DELAY IN TREATMENT GREATER THAN 15 MINUTES. THE MISONIX REPRESENTATIVE CONFIRMED THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE IN THE SCHEDULED TIMEFRAME AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DURING THE DELAY TO TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877333 NEXUS® ULTRASONIC SURGICAL ASPIRATOR SYSTEM ULTRASONIC SURGICAL ASPIRATOR SYSTEM LFL MISONIX, INC. 100-10-0000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other