BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2133516 · Received June 20, 2011

    Report

    Report Number
    3005075853-2011-02477
    Event Type
    Injury
    Date Received
    June 20, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 25, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT COLON COELIO PROCEDURE, THE INSTRUMENT WORKED WELL BUT 5 HOURS AFTER THE PROCEDURE, PATIENT HAD A FALL OF TENSION AT INTENSIVE CARE IN THE NIGHT. THE PATIENT WAS RE-OPERATED ONE. THE DOCTOR NOTICED THAT THE EPIPLOIC ARTERY BROKE AND SUTURED WITH A THREAD AND PATIENT RECEIVED BETWEEN 15 AND 18 CLOTS OF BLOOD. PATIENT IS STILL AT INTENSIVE CARE BUT HE IS GOING WELL NOW. NO DEVICE IS BEING RETURNED. ADDITIONAL INFORMATION: THE EPIPLOIC ARTERY WAS BLEEDING AFTER 4 HOURS, HE TOOK HIM BACK IN THE OPERATING ROOM. SURGEON DID NOT KNOW IF PATIENT WAS UNDER CHEMO. A BLOOD CLOT IS A TINY POCKET OF BLOOD, IT DOES MEAN AROUND 500ML FOR ONE CLOT THE EPIPLOIC ARTERY WAS DONE WITH HARMONIC, NO OTHER INSTRUMENT WAS USED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE