BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 36KHZ STRAIGHT HANDPIECE

    MDR report key: 3023121 · Received February 27, 2013

    Report

    Report Number
    3006697299-2013-00014
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    INTEGRA NEUROSCIENCES LTD
    Product Code
    LBK
    PMA / PMN Number
    K981262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INITIALLY IT WAS REPORTED THAT A CUSA HAND PIECE 36KHZ LEAKED DURING A PROCEDURE. ON (B)(6) 2013, ADDITIONAL INFO WAS RECEIVED, AND WAS DESCRIBED AS FOLLOWS: THE UNIT WAS DRIPPING FLUID DURING AN ACOUSTIC NEUROMA PROCEDURE HOWEVER, THE UNIT WAS NOT IN CONTACT WITH THE PT. THE PT WAS ANESTHETIZED AND THERE WAS A DELAY OF 20 MINUTES WHILE ANOTHER HAND PIECE WAS LOCATED AND SETUP. THE NURSE DID REPORT HOWEVER, THAT IN ESSENCE THERE WAS NO DELAY BECAUSE THE SURGEON CONTINUED TO PERFORM THE PROCEDURE UNTIL THE OTHER HAND PIECE WAS READY FOR USE. SHE WAS UNABLE TO PROVIDE PT DEMOGRAPHICS OR THE DATE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84722 CUSA EXCEL 36KHZ STRAIGHT HANDPIECE ULTRASONIC SURGICAL PRODUCTS LBK INTEGRA NEUROSCIENCES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1