BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MISONIX BONESCALPEL® HANDPIECE

    MDR report key: 18953993 · Received March 21, 2024

    Report

    Report Number
    2435119-2024-00003
    Event Type
    Malfunction
    Date Received
    March 21, 2024
    Date of Event
    December 11, 2023
    Report Date
    March 21, 2024
    Manufacturer
    MISONIX, INC.
    Product Code
    LFL
    PMA / PMN Number
    K070313
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON DECEMBER 21, 2023, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A PRODUCT OCCURRENCE REPORT FOR AN EVENT THAT OCCURRED ON DECEMBER 11, 2023, WHILE USING A BONESCALPEL® HANDPIECE (P/N: BCM-HP, S/N: (B)(6)). SPECIFICALLY, IT WAS REPORTED THAT DURING THE PROCEDURE AN "ELECTRICAL FAULT" ERROR MESSAGE WAS DISPLAYED ABOUT 5 MINUTES INTO THE DECOMPRESSION 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 23, 2024, MISONIX RECEIVED CONFIRMATION OF A DELAY IN TREATMENT GREATER THAN 15 MINUTES WHILE THE PATIENT WAS UNDER ANESTHESIA. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE DELAY IN TREATMENT. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE BONESCALPEL® HANDPIECE IN USE AT THE TIME OF THE EVENT. THERE WERE NO DEVIATIONS FOUND DURING IN-PROCESS OR FINAL INSPECTION OF THE HANDPIECE. INSPECTION AND TEST RESULTS MET SPECIFICATIONS PRIOR TO RELEASE TO COMMERCE. THE SUBJECT HANDPIECE WAS RETURNED TO MISONIX FOR EVALUATION. INSPECTION AND TESTING CONFIRMED AN ELECTRICAL FAULT WAS DISPLAYED DURING EVALUATION OF THE HANDPIECE. 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 (BCM-UM, REVISION W) (IFU) FOR THE BONESCALPEL® SYSTEM CONTAINS THE FOLLOWING WARNINGS AND CAUTIONS IN THE EVENT OF AN ELECTRICAL FAULT/NOTIFICATION: 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 OF PREPARING PATIENT FOR SURGERY TO MINIMIZE RISK TO PATIENT IN CASE OF SYSTEM MALFUNCTION. IN THE EVENT OF AN ELECTRICAL FAULT, THE MAIN SCREEN IS REPLACED BY ALERT SCREENS. REFER TO SECTION 6.4 FOR A DESCRIPTION OF THESE WARNINGS. THE CONSOLE MONITORS THE ELECTRICAL OUTPUT AT ALL TIMES AND ALERTS IN CASES WHERE THE HANDPIECE IS NOT PROPERLY CONNECTED TO THE CONSOLE, WHEN AN OUTPUT SHORT OR OPEN CIRCUIT IS DETECTED OR ELECTRICAL SAFETY IS COMPROMISED. AN ELECTRICAL FAULT SCREEN IS DISPLAYED TOGETHER WITH A STEADY AUDIBLE INDICATOR. ULTRASOUND AND IRRIGATION ARE DEACTIVATED. REQUIRES RECYCLING OF MAINS POWER SWITCH TO RE-SET. WARNING 6.1 IMMEDIATELY SUSPEND OPERATION IF ELECTRICAL FAULT APPEARS ON DISPLAY AND/OR AN ELECTRICAL FAULT AUDIBLE INDICATOR SOUNDS. REMOVE ULTRASONIC TIP FROM SURGICAL SITE. TURN MAINS POWER OFF. DO NOT TOUCH ANY METALLIC PARTS OF HANDPIECE, EXTENSION, ULTRASONIC TIP OR GENERATOR WHILE FAULT IS INDICATED. POSSIBLE CAUSE & CORRECTIVE ACTION: 1. HANDPIECE NOT CONNECTED - TURN MAINS POWER OFF, CHECK HANDPIECE CABLE CONNECTION, RESTART CONSOLE. 2. DEFECTIVE HANDPIECE - TURN MAINS POWER OFF, REPLACE HANDPIECE AND RESTART CONSOLE, IF PROBLEM PERSISTS REPLACE CONSOLE. 3. DEFECTIVE CONSOLE - TURN MAINS POWER OFF, REPLACE CONSOLE. THE INVESTIGATION HAS BEEN CONCLUDED.

    Description of Event or Problem · 0

    ON DECEMBER 21, 2023, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A PRODUCT OCCURRENCE REPORT FOR AN EVENT THAT OCCURRED ON DECEMBER 11, 2023, WHILE USING A BONESCALPEL® HANDPIECE (P/N: BCM-HP, S/N: (B)(6)). SPECIFICALLY, IT WAS REPORTED THAT DURING THE PROCEDURE AN "ELECTRICAL FAULT" ERROR MESSAGE WAS DISPLAYED ABOUT 5 MINUTES INTO THE DECOMPRESSION PROCEDURE. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED; HOWEVER, ON (B)(6) 2024, MISONIX RECEIVED CONFIRMATION OF A DELAY IN TREATMENT GREATER THAN 15 MINUTES WHILE THE PATIENT WAS UNDER ANESTHESIA. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE DELAY IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1927637 MISONIX BONESCALPEL® HANDPIECE BONESCALPEL® HANDPIECE LFL MISONIX, INC. BCM-HP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other