BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX 5MM ENDO CLIP APPLIER

    MDR report key: 6280158 · Received January 26, 2017

    Report

    Report Number
    3005075853-2017-00543
    Event Type
    Malfunction
    Date Received
    January 26, 2017
    Report Date
    January 17, 2017
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION CONTAINED IN THE JOURNAL ARTICLE RELATING TO PATIENT CONSEQUENCES REFERENCED IN THE ABSTRACT (EVENT DESCRIPTION) THAT COULD NOT BE CORRELATED TO BEING A DIRECT RESULT OF THE USE OF AN ETHICON PRODUCT: NO BLOOD TRANSFUSIONS WERE NECESSARY FOR MYOMECTOMY PROCEDURES. IN 1 CASE, FAILURE OF IDENTIFICATION OF THE UA ON ONE SIDE LED TO UNILATERAL OCCLUSION ONLY. ONE CONVERSION TO LAPAROTOMY WAS NECESSARY BECAUSE OF INTRAOPERATIVE BLEEDING. THIS PATIENT HAD A 15-CM RIGHT CORNUAL MYOMA THAT STILL DEMONSTRATED SUBSTANTIAL VASCULARITY DESPITE BILATERAL UA LIGATION. THIS BLOOD LOSS WAS LIKELY DUE TO A PREDOMINANCE OF THE BLOOD SUPPLY FROM THE OVARIAN ARTERIES. IN THIS CASE, THE MYOMECTOMY WAS COMPLETED EASILY ONCE THE ABDOMEN WAS OPENED. IN (ONE) CASE, INADVERTENT RUPTURE OF THE UA OCCURRED DUE TO APPLICATION OF A PARTIALLY CLOSED CLIP. THE UA WAS GRASPED PROXIMALLY, ENABLING ADDITIONAL CLIPS TO BE APPLIED, HEMOSTASIS WAS SECURED PROMPTLY WITHOUT SEQUELAE, AND THE PROCEDURE WAS COMPLETED LAPAROSCOPICALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE; AUST T, REYFTMANN L, ET AL. ANTERIOR APPROACH TO LAPAROSCOPIC UTERINE ARTERY LIGATION. JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY. 2011; 18(6): 792-795. ABSTRACT: HEREIN IS DESCRIBED AN ANTERIOR APPROACH TO UTERINE ARTERY LIGATION DURING LAPAROSCOPIC MYOMECTOMY AND TOTAL LAPAROSCOPIC HYSTERECTOMY. THE ANTERIOR LEAF OF THE BROAD LIGAMENT IS OPENED AND THE UTERINE ARTERY IS CLIPPED LATERAL TO ITS CROSSING OVER THE URETER. OUTCOME MEASURES WERE COMPLETION OF THE PROCEDURE LAPAROSCOPICALLY AND THE NEED FOR TRANSFUSION POSTOPERATIVELY. THIRTY-EIGHT MYOMECTOMIES AND 28 DIFFICULT TOTAL LAPAROSCOPIC HYSTERECTOMIES (PRIMARILY UTERI WITH LARGE MYOMAS) WERE PERFORMED, WITH 1 CONVERSION TO LAPAROTOMY DURING MYOMECTOMY AND 1 DURING HYSTERECTOMY, AND 1 TRANSFUSION AFTER TOTAL LAPAROSCOPIC HYSTERECTOMY. THE ANTERIOR APPROACH TO UTERINE ARTERY LIGATION IS AN ALTERNATIVE METHOD FOR TREATMENT OF UTERINE ARTERY OCCLUSION DURING LAPAROSCOPIC MYOMECTOMY OR HYSTERECTOMY PERFORMED TO TREAT LARGE MYOMAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61335 LIGAMAX 5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1