BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONESCALPEL® ULTRASONIC SURGICAL ASPIRATION SYSTEM

    MDR report key: 16697011 · Received April 6, 2023

    Report

    Report Number
    2435119-2023-00005
    Event Type
    Malfunction
    Date Received
    April 6, 2023
    Date of Event
    January 26, 2023
    Report Date
    March 1, 2023
    Manufacturer
    MISONIX, INC.
    Product Code
    LFL
    PMA / PMN Number
    K070313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON MARCH 1, 2022, MISONIX LLC., A BIOVENTUS CO., RECEIVED A PRODUCT OCCURRENCE REPORT OF A PERFORMANCE ISSUE WHILE USING THE BONESCALPEL® ULTRASONIC SURGICAL ASPIRATION SYSTEM, (PART NUMBER BCM-GN, SERIAL NUMBER (B)(4) THAT OCCURRED ON (B)(6), 2023. SPECIFICALLY, IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO ACTIVATE THE HANDPIECE CONTINUOUSLY ON THE BONESCALPEL GENERATOR. A MECHANICAL LIMIT ALERT WAS DISPLAYED. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED; HOWEVER, ON MARCH 6, 2022, MISONIX RECEIVED CONFIRMATION OF A DELAY IN TREATMENT GREATER THAN 15 MINUTES. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED. A TROUBLE SHOOTING GUIDE WITH RECOMMENDED CORRECTIVE ACTIONS FOR MECHANICAL LIMIT ALERTS IS PROVIDED IN THE INSTRUCTION FOR USE MANUAL, BCM-GN (TABLE 6.2). POSSIBLE CAUSES OF A MECHANICAL LIMIT ALERT ADDRESSED IN THE TABLE INCLUDE TIP OVERLOAD, LOOSE OR DAMAGED COMPONENTS, OR A DEFECTIVE HANDPIECE. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE BONESCALPEL® ULTRASONIC SURGICAL ASPIRATION SYSTEM, (PART NUMBER BCM-GN, SERIAL NUMBER (B)(4)). THE GENERATOR WAS MANUFACTURED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. 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 GENERATOR WAS RETURNED TO MISONIX FOR EVALUATION. INSPECTION AND TESTING CONCLUDED THE GENERATOR CONFORMED TO SPECIFICATIONS. NO MALFUNCTIONS THAT WOULD CAUSE OR CONTRIBUTE TO A MECHANICAL LIMIT ALERT WERE NOTED. NEITHER THE HANDPIECE, HANDPIECE COMPONENTS, NOR THE PROBE KIT USED DURING THE PROCEDURE WAS NOT RETURNED. AN INVESTIGATION INTO THESE AS THE CAUSE OF THE MECHANICAL LIMIT ALERT COULD NOT BE CONDUCTED. THE CUSTOMER DID NOT REPORT ADDITIONAL MECHANICAL LIMIT ALERTS AFTER THE SUBJECT EVENT. A REVIEW OF ALL POST-MARKET SURVEILLANCE DATA FOR THE BONESCALPEL® ULTRASONIC SURGICAL ASPIRATION SYSTEM, (PART NUMBER BCM-GN) DID NOT SHOW ANY ADVERSE TRENDS FOR MECHANICAL LIMIT ALERTS. THE FREQUENCY OF PRODUCT OCCURRENCE REPORTS WAS WITHIN THE FREQUENCY ESTIMATED IN THE ORIGINAL RISK MANAGEMENT REPORT. THEREFORE, THERE IS NO CHANGE IN RESIDUAL RISK, OR THE BENEFIT-RISK RATIO ESTIMATED IN THE RISK MANAGEMENT REPORT. NO FURTHER CORRECTIVE ACTION IS REQUIRED. THE INSTRUCTIONS FOR USE MANUAL (BCM-UM REVISION U) FOR THE BONESCALPEL® ULTRASONIC SURGICAL ASPIRATION SYSTEM CONTAINS THE FOLLOWING WARNINGS, CAUTIONS, AND INSTRUCTIONS TO PREVENT OR MITIGATE MECHANICAL LIMIT ALERTS. WARNING 1.2 THE BONESCALPEL 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 OR PREPARING PATIENT FOR SURGERY TO MINIMIZE RISK TO PATIENT IN CASE OF SYSTEM MALFUNCTION. SECTION 6.4 MECHANICAL LIMIT ALERT THE CONSOLE MONITORS THE ULTRASONIC OUTPUT AT ALL TIMES AND ALERTS IN CASES OF OVERLOAD OR MALFUNCTION OF THE VIBRATING ELEMENTS (HANDPIECE, EXTENSION AND ULTRASONIC TIP). A "LIMIT" ALERT IS DISPLAYED TOGETHER WITH A PULSED AUDIBLE INDICATOR AS LONG AS THE FOOTSWITCH IS DEPRESSED. ULTRASOUND AND IRRIGATION ARE DEACTIVATED TEMPORARILY. TIP OVERLOAD CAN OCCUR DURING HARD TISSUE REMOVAL WHEN APPLYING EXCESSIVE TIP PRESSURE OR FACING STRONG TISSUE RESISTANCE, E.G. FROM THICK CORTICAL BONE. THIS CAN LEAD TO STALLING OF THE ULTRASONIC TIP. A PULSED AUDIBLE SIGNAL ALERTS OF THE STALLING AND THE ULTRASOUND IS DEACTIVATED. RELEASE THE FOOTSWITCH BRIEFLY AND REDUCE THE TIP PRESSURE, E.G., BY RETRIEVING THE ULTRASONIC TIP. DEPRESS THE FOOTSWITCH AGAIN AND CONTINUE WITH REDUCED TIP PRESSURE. CONSIDER USING HIGHER AMPLITUDE SETTING OR REDUCED LOADING IF STALLING PERSISTS. .

    Description of Event or Problem · 0

    ON MARCH 1, 2022, MISONIX LLC., A BIOVENTUS CO., RECEIVED A PRODUCT OCCURRENCE REPORT OF A PERFORMANCE ISSUE WHILE USING THE BONESCALPEL® ULTRASONIC SURGICAL ASPIRATION SYSTEM, (PART NUMBER BCM-GN, SERIAL NUMBER (B)(4) THAT OCCURRED ON (B)(6), 2023. SPECIFICALLY, IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO ACTIVATE THE HANDPIECE CONTINUOUSLY ON THE BONESCALPEL GENERATOR. A MECHANICAL LIMIT ALERT WAS DISPLAYED. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED; HOWEVER, ON MARCH 6, 2022, 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
    416236 BONESCALPEL® ULTRASONIC SURGICAL ASPIRATION SYSTEM ULTRASONIC SURGICAL ASPIRATION SYSTEM LFL MISONIX, INC. BCM-GN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other