BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23KHZ STRAIGHT HANDPIECE

    MDR report key: 2765322 · Received September 26, 2012

    Report

    Report Number
    3006697299-2012-00038
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    INTEGRA LIFESCIENCES (IRELAND) LTD.
    Product Code
    LFL
    PMA / PMN Number
    K981262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR SENT TO (B)(4) ON (B)(6) 2012, WAS SENT WITH AN INCORRECT MFR REPORT # 8010219-2012-00021. AS A RESULT THIS HAS BEEN CORRECTED AND THIS INITIAL MEDWATCH IS BEING SUBMITTED TO REPLACE THE INCORRECT ONE. TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED ON (B)(4) 2012, MAKES THIS COMPLAINT REPORTABLE. A CUSA EXCEL 23 KHZ HAND PIECE WAS REPORTED TO NOT RACH MAXIMUM AMPLITUDE. THE MAXIMUM AMPLITUDE WAS ONLY 20 PERCENT. THE PT WAS ANESTHETIZED WHEN THE PROBLEM OCCURRED AND THE UNIT WAS IN CONTACT WITH THE PT. THE UNIT WAS IN USE ONLY 10 MINUTES WHEN IT MALFUNCTIONED. THE PT WAS NOT INJURED WHEN THE PROBLEM OCCURRED. THERE WERE NO OTHER INSTRUMENT OR TOOLS IN CONTACT WITH THE UNIT DURING THE PROCEDURE. THE UNIT WAS EXCHANGED FOR A SORING ULTRASONIC ASPIRATOR SO THE SURGERY COULD BE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSA EXCEL 23KHZ STRAIGHT HANDPIECE ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES (IRELAND) LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1