BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONICONE®O.R. SONICVAC

    MDR report key: 20827980 · Received December 2, 2024

    Report

    Report Number
    2435119-2024-00045
    Event Type
    Malfunction
    Date Received
    December 2, 2024
    Report Date
    December 2, 2024
    Manufacturer
    MISONIX, INC.
    Product Code
    LFL
    PMA / PMN Number
    K050776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON NOVEMBER 02, 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT INVOLVING A SONICONE®O.R. SONICVAC DISPOSABLE (PART NUMBER MXC-X2-VAC, LOT NUMBER 243036) THAT OCCURRED DURING A WOUND DEBRIDEMENT PROCEDURE. SPECIFICALLY, IT WAS REPORTED THAT "DURING THE DEBRIDEMENT THE SURGEON NOTICED THAT PLASTIC WAS ENTERING THE WOUND BED, AND THE SURGEON HAD TO DIG THEM OUT." IT WAS ESTIMATED BY EITHER THE SURGEON, THE OR STAFF, OR THE REPRESENTATIVE THAT "THEY MAY HAVE GONE 2-3MM DEEP" TO RETRIEVE THE DEBRIS. THE OR TECHNICIAN, WHO HAS BEEN COMFORTABLE SETTING UP THE EQUIPMENT, NOTICED "A BULGE IN THE TIP THAT DIDN'T SEEM NORMAL." IT IS NOT SPECIFIED IF THE NON-CONFORMING BULGE WAS NOTICED BEFORE OR AFTER USE. HOWEVER, A PHOTOGRAPH WAS PROVIDED THAT SHOWS DETERIORATION ON THE SHEATH TIP AFTER USE. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. DELAY IN TREATMENT WAS NOT REPORTED. MEDICAL INTERVENTION WAS REQUIRED TO RETRIEVE AND REMOVE THE REPORTED DEBRIS. THE SUBJECT DISPOSABLE USED AT THE TIME OF THE EVENT WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF POST MARKET SURVEILLANCE DATA FOR THE SONICONE®O.R SYSTEM DID NOT SHOW ANY SIGNIFICANT ADVERSE TRENDS. 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 OF THE DEVICE. THE INSTRUCTIONS FOR USE MANUAL (E-SOUM-OR, REVISION R) FOR THE SONICONE®O.R SYSTEM CONTAINS THE FOLLOWING WARNING, CAUTIONS, AND NOTE: WARNING 1.2 THE SONICONE O.R. 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 7.8 THE SYSTEM CHECK SHOULD ALWAYS BE DONE IN ADVANCE OF PREPARING PATIENT FOR SURGERY TO MINIMIZE RISK TO PATIENT IN CASE OF SYSTEM MALFUNCTION. CAUTION 9.2 BE CERTAIN TO CLEAR DEBRIS FROM ALL INTERNAL PASSAGES BY BRUSHING. FAILURE TO DO SO MAY HINDER STERILIZATION OF UNITS DURING AUTOCLAVING. NOTE 4.3 CONTACT OF THE ULTRASONIC TIP OR THE EXPOSED EXTENSION WITH METAL, SURGICAL INSTRUMENTS OR OTHER OBJECTS DURING ULTRASOUND USE MUST BE AVOIDED. SUCH CONTACT CAN DAMAGE THE ULTRASONIC COMPONENTS VERY EASILY AND MAY RESULT IN COMPROMISED PERFORMANCE, INCLUDING FAILURE. DISCARD ANY EXTENSIONS OR TIPS THAT SHOW SIGNS OF DAMAGES LIKE GOUGES, NICKS OR FRACTURES. EXTERNAL ASPIRATION MAY BE USED BUT IT IS RECOMMENDED THAT A PLASTIC SUCTION TIP SHOULD BE USED WHEN IN PROXIMITY WITH THE PROBE TIP. THE SUBJECT DISPOSABLE USED AT THE TIME OF THE EVENT WILL NOT BE RETURNED FOR EVALUATION. HOWEVER, PHOTOGRAPHS WERE PROVIDED WHICH SHOW DETERIORATION OF THE SUBJECT SHEATH TIP AFTER USE. THE INVESTIGATION HAS BEEN CONCLUDED.

    Description of Event or Problem · 0

    ON NOVEMBER 02, 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT INVOLVING A SONICONE®O.R. SONICVAC DISPOSABLE (PART NUMBER MXC-X2-VAC, LOT NUMBER 243036) THAT OCCURRED DURING A WOUND DEBRIDEMENT PROCEDURE. SPECIFICALLY, IT WAS REPORTED THAT "DURING THE DEBRIDEMENT THE SURGEON NOTICED THAT PLASTIC WAS ENTERING THE WOUND BED, AND THE SURGEON HAD TO DIG THEM OUT." IT WAS ESTIMATED BY EITHER THE SURGEON, THE OR STAFF, OR THE REPRESENTATIVE THAT "THEY MAY HAVE GONE 2-3MM DEEP" TO RETRIEVE THE DEBRIS. THE OR TECHNICIAN, WHO HAS BEEN COMFORTABLE SETTING UP THE EQUIPMENT, NOTICED "A BULGE IN THE TIP THAT DIDN'T SEEM NORMAL." IT IS NOT SPECIFIED IF THE NON-CONFORMING BULGE WAS NOTICED BEFORE OR AFTER USE. HOWEVER, A PHOTOGRAPH WAS PROVIDED THAT SHOWS DETERIORATION ON THE SHEATH TIP AFTER USE. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. DELAY IN TREATMENT WAS NOT REPORTED. MEDICAL INTERVENTION WAS REQUIRED TO RETRIEVE AND REMOVE THE REPORTED DEBRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2291069 SONICONE®O.R. SONICVAC SONICVAC LFL MISONIX, INC. MXC-X2-VAC 243036

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other