BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2080062 · Received May 6, 2011

    Report

    Report Number
    3005075853-2011-01841
    Event Type
    Injury
    Date Received
    May 6, 2011
    Report Date
    April 28, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAVH PROCEDURE THE DEVICE WENT THROUGH INITIAL TESTING FINE. WHEN THEY WERE USING THE DEVICE ON THE UTERINE PEDICLE, THE DEVICE WAS WORKING INTERMITTENTLY. THE DEVICE WAS NOT COAGULATING THE VESSEL. A SECOND AND THIRD DEVICE WAS PULLED AND THE SAME THING OCCURRED. THEY COULD NOT STOP THE BLEEDING. THE CASE WAS CONVERTED TO AN OPEN PROCEDURE. THE PATIENT HAD A BLOOD LOSS OF 750CC. SUTURES WERE USED TO COMPLETE THE CASE AND CONTROL THE BLEEDING. UNKNOWN IF THE PATIENT RECEIVED A BLOOD TRANSFUSION. DEVICES DISCARDED. THE PATIENT RECEIVED 2 UNITS OF RBC'S PRE AND POST OP TOTALLY FOUR UNITS. SHE HAD NOT BEEN GIVEN STEROIDS, BUT IS DIABETIC. SHE HAS COPD . HER UTERUS WAS 10.5CM X9.5X CM X 5.5 CM WHEN MEASURED POST OP. THE PROCEDURE WAS CONVERTED TO OPEN DUE TO THE BLEEDING. THE PATIENT HAD EXPERIENCED A TOPIC PREGNANCY AND THEY DID ENCOUNTER SOME ADHESIONS.

    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 Required Intervention GENERATOR AND HANDPIECE