BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 9342132 · Received November 19, 2019

    Report

    Report Number
    2210968-2019-90087
    Event Type
    Injury
    Date Received
    November 19, 2019
    Report Date
    October 30, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: THE AMERICAN JOURNAL OF SURGERY 190 (2005) 641¿643. DOI:10.1016/J.AMJSURG.2005.06.031. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: LAPAROSCOPIC-ASSISTED AXILLARY DISSECTION IN BREAST CANCER SURGERY" AUTHORS: SUSAN M.L. LIM, M.B.B.S., F.R.C.S., PH.D.*, FOONG L. LAM, M.B.B.S. CITATION: THE AMERICAN JOURNAL OF SURGERY 190 (2005) 641¿643. DOI:10.1016/J.AMJSURG.2005.06.031. THE AUTHORS REPORTED THEIR EXPERIENCE OF 30 PATIENTS WITH STAGE I AND II INVASIVE DUCTAL CARCINOMA OF THE BREAST WHO UNDERWENT LAPAROSCOPICASSISTED AXILLARY DISSECTION TOGETHER WITH SEGMENTAL MASTECTOMY. BETWEEN NOVEMBER 2003 TO JULY 2004, 30 PATIENTS (AVERAGE AGE: 47 YEARS; AGE RANGE: 34-69 YEARS) WITH T1- AND T2-INFILTRATING DUCTAL CARCINOMA OF THE BREAST SITUATED IN THE UPPER OR LOWER LATERAL QUADRANTS OF THE BREAST UNDER WENT WIDE SEGMENTAL EXCISION AND LAPAROSCOPICILLARY DISSECTION. A STAB INCISION WAS MADE FOR THE INTRODUCTION OF THE 5-MM HARMONIC SHEARS (ETHICON). THE DISSECTION COMMENCES MEDIALLY. THE DISSECTION CONTINUES DEEP TO PECTORALIS MAJOR, SWEEPING ROTTER¿S INTERPECTORAL NODES LATERALLY. NEAR THE APEX OF THE AXILLA, THE ADIPOSE TISSUE IS DISSECTED AND SWEPT FROM THE UNDERSURFACE OF THE PECTORALIS MINOR, CLEARING LEVEL II NODES UP TO THE MEDIAL BORDER OF THE PECTORALIS MINOR. THE AXILLARY ADIPOSE TISSUE WAS SWEPT LATERALLY FROM THE CHEST WALL AND INFERIORLY FROM THE AXILLARY VEIN. LYMPH NODE-BEARING TISSUE IS SWEPT INFERIORLY AND LATERALLY ALONG THE CHEST WALL. ONCE ALL 3 NERVES HAD BEEN IDENTIFIED AND DISSECTED FREE FROM THE AXILLARY CONTENTS, THE AXILLARY FAT PAD IS DISSECTED IN A LATERAL AND INFERIOR DIRECTION TO THE ANTERIOR BORDER OF THE LATISSIMUS DORSI MUSCLE AND DIVIDED. THE BREAST INCISION IS CLOSED WITH 4/0 VICRYL (ETHICON). REPORTED COMPLICATION INCLUDED SEROMA FORMATION (N-13) WHICH REQUIRED ASPIRATION, PARESTHESIA OF THE UPPER LIMB (N-1), MILD PARESTHESIA (N-?) LASTING BETWEEN 3 TO 5 DAYS, AND PAIN (N-?). IN CONCLUSION, LAPAROSCOPIC-ASSISTED AXILLARY DISSECTION OFFERS A SAFE AND IMPROVED APPROACH TO THE AXILLA THAT CAN BE INCORPORATED INTO BREAST CANCER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1138853 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention