BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LFL INSTRUMENT, ULTRASONIC SURGICAL

    MDR report key: 1431917 · Received May 4, 2009

    Report

    Report Number
    3005075853-2009-02660
    Event Type
    Malfunction
    Date Received
    May 4, 2009
    Date of Event
    April 14, 2009
    Report Date
    April 14, 2009
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 05/04/2009. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE ACTIVE BLADE BROKE OFF. NOTHING FELL INTO THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES. PROCEDURE COMPLETED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LFL INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC NA F4N67D

    Patients

    Seq Age Sex Outcome Treatment
    1 ASKU HANDPIECE| GENERATOR