BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNK)

    MDR report key: 1102944 · Received August 8, 2008

    Report

    Report Number
    1527736-2008-03925
    Event Type
    Death
    Date Received
    August 8, 2008
    Date of Event
    June 1, 2008
    Report Date
    July 16, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    LFL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 8/8/2008. INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVAL. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    RECEIVED INFO THAT A PT DEATH OCCURRED FOLLOWING AN UNK SURGERY WHERE THE SEAL ON A VESSEL MAY HAVE LET GO. NO ADD'L INFO RECEIVED AFTER SEVERAL ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC ACE (EXACT CODE UNK) LFL ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death GENERATOR| HANDPIECE