BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA NXT CONSOLE - POOL

    MDR report key: 3943581 · Received April 30, 2014

    Report

    Report Number
    3006697299-2014-00029
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    INTEGRA LIFESCIENCES IRELAND LIMITED
    Product Code
    LFL
    PMA / PMN Number
    K081459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MACHINE WAS WORKING "OK" HOOKED TO WALL SUCTION FOR ABOUT A MINUTE AND A HALF. THEN WE KEPT ENCOUNTERING A GENERAL ALARM FAULT. THIS WAS REPRESENTED BY A TRIANGLE APPEARING IN THE POWER COLUMN. IT WOULD LIGHT UP WHEN THE POWER PEDAL WAS DEPRESSED AND NO POWER WAS DELIVERED TO THE TIP. HENCE, THE ENTIRE MACHINE WAS DOWN AFTER THAT. THERE WAS NO PATIENT INJURY AND DOCTOR FINISHED WITH HIS DRILL. ADDITIONAL INFORMATION WAS REQUESTED AND ON (B)(4) 2014, THE FOLLOWING WAS PROVIDED BY THE SALES REPRESENTATIVE: ON (B)(6) 2014, A PATIENT (AGE AND GENDER UNKNOWN) WITH AN UNDERLYING MEDICAL CONDITION OF BONE CANCER UNDERWENT A T9-S1 FUSION WITH L1-L2 CORPECTOMY. IT WAS REPORTED THAT THE SURGEON WANTED TO USE 2 DIFFERENT TIPS DURING THE SURGERY (1 UPWARD AND 1 DOWNWARD TIP). SO INSTEAD OF USING 1 HANDPIECE AND CHANGING OUT THE TIPS, THE SURGICAL TECH ASSEMBLED A LOANER HANDPIECE (PRODUCT ID AND SERIAL NUMBER NOT AVAILABLE AT THIS TIME) WITH 1 TYPE OF TIP AND ASSEMBLED A HOSPITAL OWNED HANDPIECE (PRODUCT ID AND SERIAL NUMBER NOT AVAILABLE AT THIS TIME) WITH THE OTHER TIP. FIRST, THE LOANER HANDPIECE WAS USED WITH THE CUSANXT UNIT AND IT WAS WORKING FOR ABOUT A MINUTE AND A HALF. THEN, THE DOCTOR SWITCHED TO THE HOSPITAL OWNED HANDPIECE AND THE GENERAL ALARM FAULT OCCURRED. A TRIANGLE ICON WAS APPEARING IN THE POWER COLUMN OF THE CONSOLE UNIT EVERYTIME THE DOCTOR TRIED TO PRESS ON THE PEDAL. THERE WAS NO POWER TO THE HANDPIECE/TIP. THEY TRIED TO USE THE LOANER HANDPIECE THAT WAS FIRST USED AND IT GAVE THE SAME GENERAL ALARM FAULT AND TRIANGLE ICON. THE DOCTOR THEN DECIDED TO USE A DRILL TO REPLACE THE CUSA. THERE WAS NO PATIENT INJURY OR DELAY IN SURGERY. SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. PATIENT OUTCOME WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258759 CUSA NXT CONSOLE - POOL ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES IRELAND LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1