BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONASTAR® CURVED EXTENDED 23KHZ HANDPIECE

    MDR report key: 20218157 · Received September 13, 2024

    Report

    Report Number
    2435119-2024-00010
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    August 14, 2024
    Report Date
    February 12, 2025
    Manufacturer
    MISONIX, INC.
    Product Code
    LFL
    PMA / PMN Number
    K062471
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP # 1. THE CABLE JACKET AND BOTH INTERNAL, BRAIDED SHIELDS WERE SEVERED. THIS IS LIKELY A RESULT OF MISUSE. THEREFORE, THIS CONDITION MUST HAVE BEEN EVIDENT BEFORE THE CASE AND SHOULD HAVE BEEN REMOVED FROM SERVICE. FROM USER MANUAL, IFU-607: PER 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" INSPECTION IS OUTLINED IN SECTION 7.2, INSTRUCTING THE USER TO, "PERFORM AN INSPECTION OF THE HANDPIECE AND ALL COMPONENTS PRIOR TO ASSEMBLY.", AND "INSPECT THE HANDPIECE HOUSING AND CABLE FOR ANY VISUAL CRACKS." THIS IS REPEATED DURING THE ASSEMBLY INSTRUCTIONS IN SECTION 7.3 AS WELL AS IN THE REPROCESSING INSTRUCTIONS PROVIDED IN SECTION 9.2.1 AND 9.2.2. THE INVESTIGATION HAS BEEN CONCLUDED.

    Additional Manufacturer Narrative · 0

    ON AUGUST 16, 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT INVOLVING A SONASTAR® CURVED EXTENDED 23KHZ HANDPIECE (PART NUMBER CFSX6-H322) DURING A TUMOR REMOVAL SURGERY ON (B)(6) 2024. SPECIFICALLY, THE REPORT INDICATED THE HANDPIECE DEVELOPED AN ELECTRIC SPARK AND A SMALL FLAME WHERE THE CABLE JUNCTION MEETS THE BOTTOM OF THE HANDPIECE. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. DELAY IN TREATMENT WAS NOT REPORTED. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED. THE SURGEON CONFIRMED, DURING THE CASE, THAT THE HANDPIECE WAS SHOWING SIGNS OF BURNING INSULATION AT THE CABLE JUNCTION OF THE HANDPIECE. FURTHER ESCALATION OF ANY FLAME WAS PREVENTED BY THE SURGEON BY QUICKLY REMOVING THE HANDPIECE FROM THE SURGICAL FIELD. 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 (IFU-607, REVISION J) CONTAINS THE FOLLOWING WARNING, CAUTION, AND NOTE: 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. 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. THE SUBJECT HANDPIECE USED AT THE TIME OF THE EVENT HAS NOT YET BEEN RETURNED FOR EVALUATION TO DETERMINE POTENTIAL ROOT CAUSE. A FOLLOW UP REPORT WILL BE ISSUED ONCE THE HANDPIECE IS RETURNED AND THE SERIAL NUMBER CAN BE VERIFIED.

    Description of Event or Problem · 0

    ON AUGUST 16, 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT INVOLVING A SONASTAR® CURVED EXTENDED 23KHZ HANDPIECE (PART NUMBER CFSX6-H322) DURING A TUMOR REMOVAL SURGERY ON (B)(6) 2024. SPECIFICALLY, THE REPORT INDICATED THE HANDPIECE DEVELOPED AN ELECTRIC SPARK AND A SMALL FLAME WHERE THE CABLE JUNCTION MEETS THE BOTTOM OF THE HANDPIECE. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. DELAY IN TREATMENT WAS NOT REPORTED. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED. THE SURGEON CONFIRMED, DURING THE CASE, THAT THE HANDPIECE WAS SHOWING SIGNS OF BURNING INSULATION AT THE CABLE JUNCTION OF THE HANDPIECE. FURTHER ESCALATION OF ANY FLAME WAS PREVENTED BY THE SURGEON BY QUICKLY REMOVING THE HANDPIECE FROM THE SURGICAL FIELD.

    Description of Event or Problem · 0

    ON AUGUST 16, 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT INVOLVING A SONASTAR® CURVED EXTENDED 23KHZ HANDPIECE (PART NUMBER CFSX6-H322) DURING A TUMOR REMOVAL SURGERY ON (B)(6) 2024. SPECIFICALLY, THE REPORT INDICATED THE HANDPIECE DEVELOPED AN ELECTRIC SPARK AND A SMALL FLAME WHERE THE CABLE JUNCTION MEETS THE BOTTOM OF THE HANDPIECE. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. DELAY IN TREATMENT WAS NOT REPORTED. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED. THE SURGEON CONFIRMED, DURING THE CASE, THAT THE HANDPIECE WAS SHOWING SIGNS OF BURNING INSULATION AT THE CABLE JUNCTION OF THE HANDPIECE. FURTHER ESCALATION OF ANY FLAME WAS PREVENTED BY THE SURGEON BY QUICKLY REMOVING THE HANDPIECE FROM THE SURGICAL FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114199 SONASTAR® CURVED EXTENDED 23KHZ HANDPIECE CURVED EXTENDED 23KHZ HANDPIECE LFL MISONIX, INC. CFSX6-H322

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other