BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONASTAR® SHORT STRAIGHT 23 KHZ UNIVERSAL HANDPIECE

    MDR report key: 17311477 · Received July 12, 2023

    Report

    Report Number
    2435119-2023-00011
    Event Type
    Malfunction
    Date Received
    July 12, 2023
    Date of Event
    April 28, 2023
    Report Date
    July 12, 2023
    Manufacturer
    MISONIX, INC.
    Product Code
    LFL
    PMA / PMN Number
    K062471
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON MAY 23, 2023, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A PRODUCT OCCURRENCE REPORT FOR AN EVENT THAT OCCURRED ON (B)(6) 2023, WHILE USING A SONASTAR® SHORT STRAIGHT 23 KHZ UNIVERSAL HANDPIECE (P/N: CFSX6-H221, S/N: (B)(6) ) DURING A BRAIN TUMOR PROCEDURE. SPECIFICALLY, IT WAS REPORTED THAT AN ERROR MESSAGE APPEARED ON THE SCREEN. THE ERROR CODE WAS NOT SPECIFIED. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED; HOWEVER, ON JUNE 12, 2023, MISONIX RECEIVED CONFIRMATION OF A DELAY IN TREATMENT GREATER THAN 15 MINUTES. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER HANDPIECE. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE SONASTAR® SHORT STRAIGHT 23 KHZ UNIVERSAL HANDPIECE, (P/N: CFSX6-H221, S/N: (B)(6) ). THE HANDPIECE WAS MANUFACTURED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. INSPECTION AND TEST RESULTS MET SPECIFICATIONS. THE SUBJECT HANDPIECE WAS RETURNED TO MISONIX FOR EVALUATION. THE PROBE TIP KIT USED DURING THE PROCEDURE WAS NOT RETURNED OR REPORTED. INSPECTION AND TESTING CONCLUDED THE HANDPIECE CONFORMED TO SPECIFICATIONS. NO MALFUNCTIONS THAT WOULD CAUSE OR CONTRIBUTE TO AN ERROR/FAULT WERE NOTED. A REVIEW OF POST-MARKET SURVEILLANCE INVOLVING THE SONASTAR® SHORT STRAIGHT 23 KHZ UNIVERSAL HANDPIECE, PRODUCT NUMBER CFSX6-H221 DID NOT SHOW ANY SIGNIFICANT ADVERSE TRENDS. THE CURRENT FREQUENCY OF PRODUCT OCCURRENCE REPORTS FOR THE SONASTAR® SHORT STRAIGHT 23 KHZ UNIVERSAL HANDPIECE IS WITHIN THE FREQUENCY 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-601, REVISION T) CONTAINS THE FOLLOWING NOTE AND CAUTIONS TO MITIGATE HARM FROM DELAY IN TREATMENT, AND TROUBLESHOOTING STEPS IN THE EVENT OF AN ERROR MESSAGE: NOTE: 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. CAUTION: IT IS STRONGLY ADVISED THAT A STERILE BACKUP HANDPIECE BE READILY AVAILABLE IN THE OPERATING ROOM AS INSURANCE AGAINST ANY CONTAMINATION OR MALFUNCTION OF THE HANDPIECE DURING SURGERY. CAUTION: IF FAULT OCCURS, SUSPEND OPERATION OF HANDPIECE AND UNIT. DETERMINE THE CAUSE OF THE PROBLEM AND ITS SOLUTION BY CONSULTING THE TROUBLESHOOTING SECTION OF THIS MANUAL. THE SONASTAR® IS EQUIPPED WITH SELF-TEST ROUTINES, WHICH MONITOR SYSTEM OPERATION. IF A SYSTEM MALFUNCTION IS DETECTED, THE FAULT LIGHT ILLUMINATES AND AN ERROR CODE APPEARS ON THE DIGITAL DISPLAY. SHOULD A FAULT OCCUR, CONSULT TABLES 9-1 AND 9-2 IN THIS CHAPTER. NO MALFUNCTIONS THAT WOULD CAUSE OR CONTRIBUTE TO AN ERROR/FAULT WERE NOTED. INSPECTION AND TESTING OF THE RETURNED HANDPIECE CONCLUDED THE HANDPIECE EXHIBITED NORMAL OPERATION AND FUNCTION. THE HANDPIECE MET ALL SPECIFICATIONS. THEREFORE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF POST-MARKET SURVEILLANCE INVOLVING THE SONASTAR® SHORT STRAIGHT 23 KHZ UNIVERSAL HANDPIECE, PRODUCT NUMBER CFSX6-H221 DID NOT SHOW ANY SIGNIFICANT ADVERSE TRENDS. THE CURRENT FREQUENCY OF PRODUCT OCCURRENCE IS WITHIN THE FREQUENCY ESTIMATED IN THE ORIGINAL RISK MANAGEMENT REPORT. THE INSTRUCTIONS FOR USE MANUAL (IFU-601, REVISION T) CONTAINS WARNINGS, CAUTIONS, AND NOTES TO MITIGATE HARM FROM DELAY IN TREATMENT, AND TROUBLESHOOTING STEPS IN THE EVENT OF AN ERROR MESSAGE. THE INVESTIGATION HAS BEEN CONCLUDED.

    Description of Event or Problem · 0

    ON MAY 23, 2023, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A PRODUCT OCCURRENCE REPORT FOR AN EVENT THAT OCCURRED ON (B)(6) 2023, WHILE USING A SONASTAR® SHORT STRAIGHT 23 KHZ UNIVERSAL HANDPIECE (P/N: CFSX6-H221, S/N: (B)(6)) DURING A BRAIN TUMOR PROCEDURE. SPECIFICALLY, IT WAS REPORTED THAT AN ERROR MESSAGE APPEARED ON THE SCREEN. THE ERROR CODE WAS NOT SPECIFIED. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED; HOWEVER, ON JUNE 12, 2023, MISONIX RECEIVED CONFIRMATION OF A DELAY IN TREATMENT GREATER THAN 15 MINUTES. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749216 SONASTAR® SHORT STRAIGHT 23 KHZ UNIVERSAL HANDPIECE ULTRASONIC SURGICAL SYSTEM HANDPIECE LFL MISONIX, INC. CSFX6-H221

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other