BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CONTOUR CURVED CUTTER STAPLER

    MDR report key: 7728578 · Received July 27, 2018

    Report

    Report Number
    3005075853-2018-11654
    Event Type
    Injury
    Date Received
    July 27, 2018
    Date of Event
    September 1, 2005
    Report Date
    July 2, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    TITLE: CAN A CURVED STAPLER MADE FOR OPEN SURGERY BE USEFUL IN LAPAROSCOPIC LOWER RECTAL RESECTIONS? TECHNIQUE AND EXPERIENCE OF A SINGLE CENTRE. AUTHOR : FRANCESCO SAVERIO MARI*, MARCELLO GASPARRINI, GIUSEPPE NIGRI, GIAMMAURO BERARDI, GIOVANNI GUGLIELMO LARACCA, BARBARA FLORA, ALESSANDRA PANCALDI, ANTONIO BRESCIA. CITATION: THE SURGEON 11 (2013) S23-S26; DOI: HTTP://DX.DOI.ORG/10.1016/J.SURGE.2012.10.001. THIS RETROSPECTIVE STUDY AIMED TO PRESENT A TECHNIQUE USING THE CONTOUR CURVED STAPLER (CCS), MADE FOR OPEN SURGERY, IN LAPAROSCOPY AND THE RESULTS OF THIS EXPERIENCE. BETWEEN SEP 2005 AND SEP 2011, 45 PATIENTS (N=27 MALE AND N=18 FEMALE; MEAN AGE OF 61 YEARS [RANGED 40-82 YEARS]) UNDERWENT LOWER LAPAROSCOPIC ANTERIOR RECTAL RESECTION IN WHICH THE CCS WAS USED TO PERFORM SECTION OF THE RECTUM. IN THE PROCEDURE THE HAND ACCESS DEVICE, LAPDISC, WAS PLACED IN THE INCISION AND THROUGH THIS, THE CCS STAPLER WAS PLACE INTO THE PELVIC CAVITY. THE RECTUM WAS INCLUDED BETWEEN THE STAPLER¿S JAWS BY AN ANTI-CLOCKWISE MOVEMENT. THE RECTUM WAS CLOSED AND SECTIONED IN A SINGLE SHOT. POSTOPERATIVELY, THERE WERE 2 PATIENTS WHO HAD ANASTOMOTIC LEAKS AND IN ONE PATIENT A TEMPORARY ILEOSTOMY WAS PERFORMED. NO INTRAOPERATIVE AND POSTOPERATIVE STAPLE LINE BLEEDING OCCURRED AND NONE OF THE PATIENTS SHOWED AN ANASTOMOTIC STENOSIS AT 1 YEAR FOLLOW-UP. THE LAPAROSCOPIC USE OF CCS USING OUR TECHNIQUE SEEMS EASY AND EFFECTIVE AS SHOWED BY THE COMPLICATION RATE THAT WERE COMPARABLE TO THOSE REPORTED WITH THE TRADITIONAL LAPAROSCOPIC TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568027 UNKNOWN CONTOUR CURVED CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention