BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXUS® STANDARD HANDPIECE

    MDR report key: 16906899 · Received May 10, 2023

    Report

    Report Number
    2435119-2023-00007
    Event Type
    Malfunction
    Date Received
    May 10, 2023
    Date of Event
    March 3, 2023
    Report Date
    May 10, 2023
    Manufacturer
    MISONIX, INC.
    Product Code
    LFL
    PMA / PMN Number
    190160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON APRIL 7, 2023, MISONIX LLC., A BIOVENTUS CO., RECEIVED A PRODUCT OCCURRENCE REPORT ON A NEXUS® STANDARD HANDPIECE, (PART NUMBER 100-21-0001, SERIAL NUMBER (B)(6)) THAT OCCURRED ON (B)(6) 2023, DURING A LUMBAR FUSION. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED; HOWEVER, ON APRIL 11, 2023, MISONIX RECEIVED CONFIRMATION OF A DELAY IN TREATMENT GREATER THAN 15 MINUTES. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE NEXUS® STANDARD HANDPIECE, (PART NUMBER 100-21-0001, SERIAL NUMBER (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 CONFIRMED A DAMAGED HANDPIECE CONNECTOR. A REVIEW OF POST-MARKET SURVEILLANCE INVOLVING THE NEXUS® STANDARD HANDPIECE, PRODUCT NUMBER 100-21-0001 DID NOT SHOW ANY SIGNIFICANT ADVERSE TRENDS. THE CURRENT FREQUENCY OF PRODUCT OCCURRENCE REPORTS FOR THE NEXUS STANDARD 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 (100-10-1000, REVISION G) FOR THE NEXUS® ULTRASONIC SURGICAL ASPIRATION SYSTEM CONTAINS THE FOLLOWING WARNINGS AND CAUTIONS TO MITIGATE DELAY IN TREATMENT: WARNING THE NEXUS® ULTRASONIC SURGICAL ASPIRATOR 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 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 IT IS STRONGLY ADVISED THAT A STERILE BACKUP HANDPIECE BE READILY AVAILABLE IN THE OPERATING ROOM AS INSURANCE ANY CONTAMINATION OR MALFUNCTION OF THE HANDPIECE USED DURING SURGERY. THE INSTRUCTIONS FOR USE MANUAL (100-21-1000, REVISION C) FOR THE NEXUS® STANDARD HANDPIECE CONTAINS INSTRUCTIONS FOR HANDPIECE ASSEMBLY AND DISASSEMBLY TO PRECLUDE CONNECTOR DAMAGE: HANDPIECE ASSEMBLY AND DISASSEMBLY CAUTION THE HANDPIECE MUST BE PLACED INTO THE COUNTER WRENCH. DO NOT ATTEMPT TO TIGHTEN OR UNTIGHTEN HANDPIECE COMPONENTS BY HOLDING THE HANDPIECE CASE OR ENDCAP. ALWAYS USE THE T-WRENCH WRENCH WHEN TIGHTENING OR UN-TIGHTENING THE TIP OR AN EXTENSION. NEVER APPLY A PIPE OR STRAP WRENCH TO THE HANDPIECE CASE. DO NOT OVER-TIGHTEN THE TIP OR THE EXTENSION. CAUTION ALWAYS TIGHTEN OR UN-TIGHTEN THE PROBE COVER BY HAND AND WITHOUT USING ANY WRENCHES. DO NOT OVER-TIGHTEN THE PROBE COVER. CAUTION ALWAYS HOLD THE HANDPIECE AT ITS METALLIC ENDCAP WHEN TIGHTENING OR UN-TIGHTENING THE IRRIGATION TUBING. ALWAYS TIGHTEN OR UN-TIGHTEN THE IRRIGATION TUBING BY HAND AND WITHOUT USING ANY WRENCHES. DO NOT OVER- TIGHTEN THE TUBING CONNECTOR. HANDPIECE INSPECTION (PRIOR TO ASSEMBLY: INSPECT THE HANDPIECE HOUSING AND FRONT COVER FOR DAMAGE AND SIGNS OF WEAR SUCH AS SCRATCHES, CRACKS, AND CHIPS. INSPECT THE HANDPIECE CABLE TO ENSURE IT IS NOT CUT OR FRAYED. INSPECT THE HANDPIECE CABLE CONNECTOR, CONNECTOR PINS, AND THE TETHERED CAP TO ENSURE THEY ARE NOT DAMAGED. PLACE THE TETHERED CAP ON THE CONNECTOR AFTER INSPECTION AND LEAVE IN PLACE UNTIL CONNECTION TO THE GENERATOR. DO NOT USE DAMAGED HANDPIECES OR HANDPIECE COMPONENTS. CONTACT MISONIX CUSTOMER SERVICE IF DAMAGE IS NOTED. THE NEXUS® HANDPIECE SHOULD BE FULLY INSPECTED FOR LOOSE OR MISSING COMPONENTS AND TESTED FOR PROPER OPERATION PRIOR TO EACH PROCEDURE.

    Description of Event or Problem · 0

    ON APRIL 7, 2023, MISONIX LLC., A BIOVENTUS CO., RECEIVED A PRODUCT OCCURRENCE REPORT ON A NEXUS® STANDARD HANDPIECE, (PART NUMBER 100-21-0001, SERIAL NUMBER (B)(6)) THAT OCCURRED ON (B)(6) 2023, DURING A LUMBAR FUSION. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED; HOWEVER, ON APRIL 11, 2023, 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
    688021 NEXUS® STANDARD HANDPIECE ULTRASONIC SURGICAL ASPIRATOR SYSTEM HANDPIECE LFL MISONIX, INC. 100-21-0001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other