BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UCSA EXCEL 36KHZ CURVED EXTENDED PRECISION TIP

    MDR report key: 2852416 · Received November 13, 2012

    Report

    Report Number
    3006697299-2012-00047
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 22, 2012
    Report Date
    November 13, 2012
    Manufacturer
    INTEGRA LIFESCIENCES IRELAND LIMITED
    Product Code
    LBK
    PMA / PMN Number
    K981262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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

    DURING A TUMOR RESECTION A 36 KHZ HAND PIECE WITH A CURVED EXTENDED PRECISION TIP THAT WAS USED IN COMBINATION WITH A CEM NOSE CONE FOR COAGULATION. DURING THE PROCEDURE IT WAS REPORTED THAT TWO TIPS MELTED AND WERE BROKEN AT THE END OF THE TIP. THIS EVENT CAUSED A TWENTY MINUTE INCREASE IN SURGERY TIME. THE PT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UCSA EXCEL 36KHZ CURVED EXTENDED PRECISION TIP ULTRASONIC SURGICAL PRODUCTS. LBK INTEGRA LIFESCIENCES IRELAND LIMITED 1120859

    Patients

    Seq Age Sex Outcome Treatment
    1