BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXUS® SONASTAR® LONG HANDPIECE

    MDR report key: 23479204 · Received November 5, 2025

    Report

    Report Number
    2435119-2025-00038
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    September 23, 2025
    Report Date
    November 5, 2025
    Manufacturer
    MISONIX, INC.
    Product Code
    LFL
    PMA / PMN Number
    K231117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON OCTOBER 02, 2025, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT INVOLVING A NEXUS® SONASTAR® LONG HANDPIECE (PART NUMBER 100-25-0001, SERIAL NUMBER (B)(6)) DURING A PROCEDURE ON (B)(6) 2025. SPECIFICALLY, THE REPORTER INDICATED THAT "DURING THE SURGERY, A LIVER RESECTION, THE ELECTRICAL ERROR ILF1 APPEARED, AND IT REMAINED IN A CONSTANT WAY AVOIDING THE CORRECT FUNCTIONING OF THE HANDPIECE." A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED; HOWEVER, ON OCTOBER 06, 2025, MISONIX RECEIVED CONFIRMATION OF A DELAY IN TREATMENT GREATER THAN 15 MINUTES WHILE THE PATIENT WAS UNDER ANESTHESIA WHICH CAUSED THE PROCEDURE TO BE PROLONGED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE DELAY. A REVIEW OF ALL AVAILABLE POST MARKET SURVEILLANCE DATA FOR THE NEXUS® SYSTEM HAS SHOWN NO INCREASING TRENDS ON THE SINGLE FAULT HAVE BEEN IDENTIFIED FOR PART NUMBER 100-25-0001. THE CURRENT FREQUENCY IS BELOW THE LIKELIHOOD OF OCCURRENCE IN THE RISK MANAGEMENT REPORT. THERE IS NO CHANGE IN RESIDUAL RISK OR RISK-BENEFIT. THE INSTRUCTIONS FOR USE MANUAL (100-10-1000, REVISION L) FOR THE NEXUS® ULTRASONIC SURGICAL ASPIRATION SYSTEM CONTAINS THE FOLLOWING WARNING AND CAUTIONS: 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. REFER TO SECTION 7.11 - SYSTEM CHECK. CAUTION THE NEXUS® SYSTEM SHOULD BE FULLY TESTED AND INSPECTED PRIOR TO EACH PROCEDURE. THE CONSOLE, FOOTSWITCH, HANDPIECES, ALL CABLES AND ACCESSORIES SHOULD BE EXAMINED FOR PROPER APPEARANCE AND CONDITION. FAULT TYPE: ILF. FAULT ACTION: SYSTEM FUNCTIONS AUTOMATICALLY DISABLE. PRESSING THE SYSTEM RESET BUTTON REBOOTS THE SYSTEM. "NEXUS" SPLASH SCREEN APPEARS FOLLOWED BY THE PRIMING SCREEN. PRIMING SCREEN MAY BE SKIPPED. *SKIPPING PRIMING SCREEN RETURNS USER TO THE MAIN SCREEN. POSSIBLE CAUSE: ILF: DAMAGED CONSOLE OR HANDPIECE CORRECTIVE ACTION: PRESS THE SYSTEM RESET BUTTON AND TRY AGAIN. IF PROBLEM PERSISTS, REPLACE HANDPIECE AND TRY AGAIN. IF CORRECTIVE ACTION STEPS ABOVE ARE FOLLOWED AND FAULT CONTINUES, THE CONSOLE MAY NEED TO BE REPLACED. WARNING IMMEDIATELY SUSPEND OPERATION IF A PERSISTENT ELECTRICAL FAULT APPEARS ON DISPLAY AND/OR AN ELECTRICAL FAULT AUDIBLE INDICATOR SOUNDS. REMOVE ULTRASONIC PROBE TIP FROM SURGICAL SITE. DO NOT TOUCH ANY METALLIC PARTS OF HANDPIECE, EXTENSION, ULTRASONIC PROBE TIP OR GENERATOR WHILE FAULT IS INDICATED. THERE IS NO IMPACT ON SAFETY. THE CONSOLE MONITORS THE ELECTRICAL OUTPUT TO THE HANDPIECE AT ALL TIMES. IF THERE IS AN IMBALANCE OF CURRENT THE GENERATOR AUTOMATICALLY DISABLES THE ULTRASOUND OUTPUT TO PREVENT UNSAFE PATIENT OR USER LEAKAGE CURRENT. IF THIS OCCURS, THE ELECTRICAL FAULT CODE IS DISPLAYED ON THE FRONT PANEL, AND AN AUDIBLE TONE CAN BE HEARD. THE IFU INCLUDES A WARNING TO DISCONTINUE USE IF AN ELECTRICAL FAULT OCCURS. THE MISONIX IFU INCLUDES A WARNING TO FOLLOW THE HOSPITAL BACKUP EQUIPMENT PROTOCOL IF REQUIRED. IT HAS NOT YET BEEN SPECIFIED IF THE HANDPIECE USED AT THE TIME OF THE EVENT WILL BE RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    ON OCTOBER 02, 2025, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT INVOLVING A NEXUS® SONASTAR® LONG HANDPIECE (PART NUMBER 100-25-0001, SERIAL NUMBER (B)(6)) DURING A PROCEDURE ON (B)(6) 2025. SPECIFICALLY, THE REPORTER INDICATED THAT "DURING THE SURGERY, A LIVER RESECTION, THE ELECTRICAL ERROR ILF1 APPEARED, AND IT REMAINED IN A CONSTANT WAY AVOIDING THE CORRECT FUNCTIONING OF THE HANDPIECE." A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED; HOWEVER, ON OCTOBER 06, 2025, MISONIX RECEIVED CONFIRMATION OF A DELAY IN TREATMENT GREATER THAN 15 MINUTES WHILE THE PATIENT WAS UNDER ANESTHESIA WHICH CAUSED THE PROCEDURE TO BE PROLONGED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2649488 NEXUS® SONASTAR® LONG HANDPIECE LONG HANDPIECE LFL MISONIX, INC. 100-25-0001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other