BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONASTAR® STANDARD LONG CURVED PROBE

    MDR report key: 18952209 · Received March 21, 2024

    Report

    Report Number
    2435119-2024-00002
    Event Type
    Malfunction
    Date Received
    March 21, 2024
    Date of Event
    December 19, 2024
    Report Date
    March 21, 2024
    Manufacturer
    MISONIX, INC.
    Product Code
    LFL
    PMA / PMN Number
    K062471
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON JANUARY 10, 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A PRODUCT OCCURRENCE REPORT FOR AN EVENT THAT OCCURRED ON DECEMBER 19, 2023, WHILE USING A SONASTAR® STANDARD LONG CURVED PROBE (P/N: MXA-D218, S/N: (B)(6)) WITH A SONASTAR® ULTRASONIC SHORT STRAIGHT 23KHZ UNIVERSAL HANDPIECE (P/N: CFSX6-H321, S/N: (B)(6)) AND A SONASTAR® ULTRASONIC SURGICAL ASPIRATION SYSTEM (P/N: SYSTEM-M360-0, S/N: (B)(6)) DURING A BRAIN TUMOR RESECTION. SPECIFICALLY, IT WAS REPORTED THAT AN E1 FAULT MESSAGE WAS DISPLAYED DURING THE PROCEDURE. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED; HOWEVER, ON FEBRUARY 20, 2024, MISONIX RECEIVED CONFIRMATION OF A DELAY IN TREATMENT OF 45 MINUTES WHILE THE PATIENT WAS UNDER ANESTHESIA. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE SONASTAR® STANDARD LONG CURVED PROBE, THE SONASTAR® ULTRASONIC SHORT STRAIGHT 23KHZ UNIVERSAL HANDPIECE, AND THE SONASTAR® ULTRASONIC SURGICAL ASPIRATION SYSTEM IN USE AT THE TIME OF THE EVENT. THERE WERE NO DEVIATIONS FOUND DURING IN-PROCESS OR FINAL INSPECTION OF THE DEVICES. INSPECTION AND TEST RESULTS MET SPECIFICATIONS PRIOR TO RELEASE TO COMMERCE. A REVIEW OF ALL AVAILABLE POST MARKET SURVEILLANCE DATA HAS NOT SHOWN ADVERSE TRENDS RELATED TO THIS OR SIMILAR EVENTS. THE CURRENT FREQUENCY OF OCCURRENCE IS WITHIN THE FREQUENCY IN THE ORIGINAL RISK MANAGEMENT REPORT. THERE IS NO CHANGE TO THE RESIDUAL RISK OR RISK-BENEFIT RATIO. THE INSTRUCTIONS FOR USE MANUAL (IFU-607, REVISION J) CONTAINS THE FOLLOWING WARNING, CAUTIONS, AND NOTES TO MITIGATE HARM FROM DELAY IN TREATMENT: WARNING 1.2: THE SONASTAR® 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 6.10: THE SYSTEM CHECK SHOULD ALWAYS BE DONE IN ADVANCE OF PREPARING THE PATIENT FOR SURGERY TO MINIMIZE RISK TO PATIENT IN CASE OF SYSTEM MALFUNCTION. CAUTION 6.13: IF A FAULT OCCURS, SUSPEND OPERATION OF HANDPIECE AND UNIT. DETERMINE THE CAUSE OF THE PROBLEM AND ITS SOLUTION BY CONSULTING THE TROUBLESHOOTING TABLES FOUND IN SECTION 10 OF THIS MANUAL. CAUTION 10.1: IMPROPER USE OR ADJUSTMENT OF THIS DEVICE MAY INVALIDATE THE MISONIX, LLC WARRANTY AGREEMENT. CONTACT YOUR AUTHORIZED MISONIX, LLC REPRESENTATIVE BEFORE ATTEMPTING TO TROUBLESHOOT THIS DEVICE IN ANY MANNER OTHER THAN THOSE SPECIFIED IN THIS MANUAL. THERE ARE NO USER SERVICEABLE PARTS. NOTE 4.3 IT IS HIGHLY RECOMMENDED TO HAVE BACKUPS OF ALL SINGLE- USE ITEMS AVAILABLE IN CASE OF UNFORESEEN EVENTS. NOTE 6.1: THE SONASTAR® 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, AND THE INITIAL SYSTEM SETUP TEST SHOULD BE PERFORMED WITH EACH HANDPIECE TO ENSURE PROPER OPERATION. NOTE 10.1: THE FOLLOWING TABLES DO NOT ATTEMPT TO ANTICIPATE ALL POSSIBLE FAILURES. ANY FAULT NOT LISTED IN THE TABLES MUST BE REFERRED TO AN AUTHORIZED MISONIX, LLC TECHNICAL REPRESENTATIVE. THE SONASTAR® ULTRASONIC SURGICAL ASPIRATION SYSTEM GENERATOR 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 "E1" FAULT CODE IS DISPLAYED ON THE FRONT PANEL AND AN AUDIBLE TONE CAN BE HEARD. THE GENERATOR GIVING AN E1 FAULT CODE IS AN INDICATION THAT THERE IS A PROBE TIP PROBLEM. THE SUBJECT DISPOSABLE USED AT THE TIME OF THE EVENT WAS DISCARDED BY THE HOSPITAL AND WILL NOT BE RETURNED FOR EVALUATION. THE CUSTOMER CONFIRMED THE CONSOLE USED AT THE TIME OF THE EVENT WILL NOT BE RETURNED FOR EVALUATION. MISONIX HAS FOLLOWED UP WITH THE ACCOUNT FOR THE RETURN OF THE HANDPIECE AND HAS NOT YET RECEIVED A RESPONSE AS OF THE DATE OF THIS REPORT, THEREFORE A THOROUGH INVESTIGATION INTO THE ROOT CAUSE CANNOT BE CONDUCTED. THIS INVESTIGATION WILL BE UPDATED IF THE PRODUCT IS RECEIVED BY MISONIX AT A LATER DATE.

    Description of Event or Problem · 0

    ON JANUARY 10, 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A PRODUCT OCCURRENCE REPORT FOR AN EVENT THAT OCCURRED ON DECEMBER 19, 2023, WHILE USING A SONASTAR® STANDARD LONG CURVED PROBE (P/N: MXA-D218, S/N: (B)(6)) WITH A SONASTAR® ULTRASONIC SHORT STRAIGHT 23KHZ UNIVERSAL HANDPIECE (P/N: CFSX6-H321, S/N: (B)(6)) AND A SONASTAR® ULTRASONIC SURGICAL ASPIRATION SYSTEM (P/N: SYSTEM-M360-0, S/N: (B)(6)) DURING A BRAIN TUMOR RESECTION. SPECIFICALLY, IT WAS REPORTED THAT AN E1 FAULT MESSAGE WAS DISPLAYED DURING THE PROCEDURE. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED; HOWEVER, ON FEBRUARY 20, 2024, MISONIX RECEIVED CONFIRMATION OF A DELAY IN TREATMENT OF 45 MINUTES WHILE THE PATIENT WAS UNDER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1700970 SONASTAR® STANDARD LONG CURVED PROBE STANDARD LONG CURVED PROBE LFL MISONIX, INC. MXA-D218 213285

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other