BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSA NXT CONSOLE (115-230V)

    MDR report key: 4001411 · Received July 16, 2014

    Report

    Report Number
    3006697299-2014-00066
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    June 17, 2014
    Report Date
    July 7, 2014
    Manufacturer
    INTEGRA LIFESCIENCES (IRELAND) LIMITED
    Product Code
    LFL
    PMA / PMN Number
    K081459
    Adverse Event
    Yes
    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 BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THIS IS THE FOURTH OF FOUR REPORTS (SAME PT, SAME INCIDENT, DIFFERENT PRODUCT IDS/SERIAL NUMBERS). THIS REPORT IS IN REGARDS TO THE CUSA NXT CONSOLE. LINKED TO MFG REPORT NUMBER: 8010219-2014-00033 (1523000M7P; 24K NEURO PROBE SHORT WITH SERIAL NUMBER: (B)(4)), MFG REPORT NUMBER: 8010219-2014-00034 (1523000M7P; 24K NEURO PROBE SHORT SERIAL NUMBER: (B)(4)) AND MFG REPORT NUMBER: 8010219-2014-00032 (1517079 SELECTOR STERILE TUBING KIT). (B)(4) WAS RECEIVED ON (B)(4) 2014 WITH THE FOLLOWING INFP: AGE AT TIME OF EVENT: (B)(6) FEMALE; DATE OF EVENT: (B)(6) 2014; DATE OF THIS REPORT: (B)(4) 2014. ORIGINAL INTENDED PROCEDURE: ORBITAL DECOMPRESSION AND BONE REMOVAL. PRODUCT RETURNED TO MFR ON (B)(4) 2014. DURING ORBITAL DECOMPRESSION AND BONE REMOVAL, THE CUSA WAS BEING USED TO REMOVE BONE TISSUE. THE HANDPIECE HAS AN IRRIGATION AND SUCTION SLEEVE AND A TIP IS INSERTED WHICH VIBRATES LONGITUDINALLY TO BREAK UP BONE OR TISSUE. DURING USE, THE TIP WAS GETTING PLENTY OF IRRIGATION DESIGNED TO KEEP IT COOL, BUT A LOT OF IRRIGATION WAS ALSO COMING OUT OF THE BACK OF THE HANDPIECE, WHICH SHOULD NOT HAPPEN. THE FIRST HANDPIECE WAS REMOVED AND A SECOND HANDPIECE CONNECTED BUT FLUID STILL LEAKED OUT OF THE BACK OF THE HANDPIECE. TWO SMALL THERMAL BURNS WERE NOTED ON THE RIGHT LATERAL CANTHUS, MEASURING 5X3MM AND 4X2MM. WHEN THIS WAS IDENTIFIED, THE PHYSICIAN STOPPED USING THE DEVICE. THE DEVICE WAS IN USE FOR LESS THAN 2 MINUTES. THE THERMAL BURNS WERE MINOR AND REPAIRED AT THAT TIME. THE PT LEFT THE OPERATING ROOM IN STABLE CONDITION. AT THIS TIME UNK WHETHER FURTHER REPAIR OF THERMAL INJURY WILL BE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414699 CUSA NXT CONSOLE (115-230V) ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES (IRELAND) LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other| R