BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION * SURG DEV, CURVED SHEARS, ENDO

    MDR report key: 2994854 · Received March 8, 2013

    Report

    Report Number
    1527736-2013-00007
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    January 1, 2011
    Report Date
    February 12, 2013
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RETURNED FOR ANALYSIS SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A "SOCIETY OF THORACIC SURGEONS" ARTICLE DATED 11-05-2012 THAT FROM JANUARY 2004 TO DECEMBER 2011, 557 PATIENTS UNDERWENT VATS ANATOMIC LUNG RESECTION FOR PRIMARY NON-SMALL CEL LUNG CANCER. ENERGY DEVICES USED WERE HARMONIC SCALPEL, LIGASURE OR ENSEAL. THE ARTICLES "CODE" HARMONIC ULTRASONIC COAGULATING SHEARS AS "UCS". THE ARTICLE MENTIONS "A CRITICAL COMPLICATION OF BLEEDING WAS DEFINED AS AN EVENT THAT RESULTED IN AN ADDITIONAL THORACOTOMY, HEMOSTATIC PROCEDURE, OR BLOOD TRANSFUSION." "THE MOST COMMONLY USED DEICES DURING VESSEL INJURY WERE UCS IN 9 CASES." AN AORTIC PERFORATION INJURY WAS CAUSED BY USC DURING MEDIASTINAL DISSECTION OF A LEFT LUNG CANCER. THIS AORTIC INJURY BY USC WAS ONLY A THERMAL INJURY CAUSEC BY TGE TIOP OF THE UCS....THE OTHER 8 CASES BY UCS WERE INJURIES ON DISORIENED OR MISRECOGNIZED VESSELS DURING TISSUE DISSECTION." NO ADDITIONAL INFORMATION IS AVAILABLE AND MULTIPLE ATTEMPTS HAVE BEEN MADE TO SPEAK WITH THE SURGEON WITHOUT SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99350 ULTRACISION * SURG DEV, CURVED SHEARS, ENDO ULTRACISION GEI ETHICON ENDO SURGERY, INC (CINCINNATI) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GENERATOR AND HANDPIECE