BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXUS® ULTRASONIC SURGICAL ASPIRATOR SYSTEM

    MDR report key: 17144850 · Received June 16, 2023

    Report

    Report Number
    2435119-2023-00010
    Event Type
    Malfunction
    Date Received
    June 16, 2023
    Date of Event
    May 4, 2023
    Report Date
    June 16, 2023
    Manufacturer
    MISONIX, INC.
    Product Code
    LFL
    PMA / PMN Number
    K190160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2023, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A PRODUCT OCCURRENCE REPORT FOR AN EVENT THAT OCCURRED ON (B)(6) 2023, WHILE USING A NEXUS® CONSOLE (P/N: 100-10-0000, S/N:(B)(6)) DURING A BRAIN TUMOR RESECTION. SPECIFICALLY, IT WAS REPORTED THAT SEVERAL HOURS INTO THE PROCEDURE THE CONSOLE DISPLAYED AN HBF POWER SUPPLY FAULT MESSAGE. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED; HOWEVER, ON (B)(6) 2023, MISONIX RECEIVED CONFIRMATION OF A DELAY IN TREATMENT GREATER THAN 15 MINUTES. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED. THE DISPLAY OF AN HBF POSER SUPPLY FAULT MESSAGE IS A FAIL-SAFE CONDITION. THE CONSOLE CONTINUOUSLY MONITORS THE INTERNAL POWER SUPPLIES AND DISPLAYS THE FAULT MESSAGE WHEN COMPROMISED. ULTRASOUND AND IRRIGATION ARE DEACTIVATED. THEREFORE, THE PROBABILITY OF USER OR PATIENT INJURY IS REMOTE. 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 HANDPIECE PART NUMBER AND SERIAL NUMBER, AND THE DISPOSABLE PROBE TIP PART NUMBER AND LOT NUMBER USED AT THE TIME OF THE EVENT WERE NOT REPORTED AND WILL NOT BE RETURNED FOR EVALUATION. THE SUBJECT GENERATOR WAS RETURNED TO MISONIX. INSPECTION AND TESTING CONFIRMED AN HBF POWER SUPPLY FAULT WAS DISPLAYED DURING EVALUATION OF THE CONSOLE. 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 INSTRUCTIONS FOR USE MANUAL (100-10-1000, REVISION G) (IFU) FOR THE NEXUS® ULTRASONIC SURGICAL ASPIRATION SYSTEM CONTAINS THE FOLLOWING WARNINGS AND CAUTIONS TO MITIGATE DELAY IN TREATMENT: 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 IFU HAS INSTRUCTIONS ON HOW TO RESET THE SYSTEM IF A POWER IF A POWER SUPPLY FAULT OCCURS. REFER TO SECTION 9.3 OF THE IFU. 9.3 POWER SUPPLY FAULTS THE CONSOLE MONITORS THE INTERNAL POWER SUPPLIES AT ALL TIMES AND FAULTS IN CASES WHEN THEY ARE COMPROMISED. A SYSTEM RESET SCREEN IS DISPLAYED TOGETHER WITH AN AUDIBLE INDICATOR. ULTRASOUND AND IRRIGATION ARE DEACTIVATED. IF THE SYSTEM CANNOT BE RESET, THE CONSOLE MAY NEED TO BE REPLACED. FAULT TYPE: HBF - POWER SUPPLY FAULT POSSIBLE CAUSE: DAMAGED CONSOLE CORRECTIVE ACTION: PRESS THE SYSTEM RESET BUTTON AND TRY AGAIN. IF CORRECTIVE ACTION STEPS ABOVE ARE FOLLOWED AND FAULT CONTINUES, THE CONSOLE MAY NEED TO BE REPLACED.

    Description of Event or Problem · 0

    ON (B)(6) 2023, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A PRODUCT OCCURRENCE REPORT FOR AN EVENT THAT OCCURRED ON (B)(6) 2023, WHILE USING A NEXUS® CONSOLE (P/N: 100-10-0000, S/N: (B)(6)) DURING A BRAIN TUMOR RESECTION. SPECIFICALLY, IT WAS REPORTED THAT SEVERAL HOURS INTO THE PROCEDURE THE CONSOLE DISPLAYED AN HBF POWER SUPPLY FAULT MESSAGE. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED; HOWEVER, ON (B)(6) 2023, MISONIX RECEIVED CONFIRMATION OF A DELAY IN TREATMENT GREATER THAN 15 MINUTES. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458093 NEXUS® ULTRASONIC SURGICAL ASPIRATOR SYSTEM ULTRASONIC SURGICAL ASPIRATOR SYSTEM LFL MISONIX, INC. 100-10-0000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other