BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2162371 · Received July 14, 2011

    Report

    Report Number
    3005075853-2011-02879
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 11, 2011
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. ONLY YEAR KNOWN, ASSUMED 1ST DAY OF MONTH (JULY) THAT COMPLAINT WAS REPORTED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BOTTOM PIECE OF THE JAW BROKE OFF ONCE THE DEVICE WAS REMOVED FROM THE PATIENT. PER THE CALLER, THE DEVICE WAS ACTIVATED NEAR A CLIP. THE PIECE DID NOT FALL INTO THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO OTHER DETAILS OF THE EVENT ARE KNOWN. NO PATIENT CONSEQUENCE REPORTED. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE