BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEX 60 ARTICULATING

    MDR report key: 8061177 · Received November 12, 2018

    Report

    Report Number
    3005075853-2018-14340
    Event Type
    Injury
    Date Received
    November 12, 2018
    Report Date
    October 17, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). BATCH # UNK. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT JOURNAL ARTICLE: TITLE: "PERIOPERATIVE HEMORRHAGIC COMPLICATIONS AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY: FOUR-YEAR EXPERIENCE OF A BARIATRIC CENTER OF EXCELLENCE," AUTHORS: FRANCESCO DE ANGELIS, MOHAMED ABDELGAWAD, MARIO RIZZELLO, CONSALVO MATTIA, GIANFRANCO SILECCHIA. CITATION: SURG ENDOSC (2017) 31: 3547¿3551; DOI 10.1007/S00464-016-5383-Y. THIS RETROSPECTIVE STUDY AIMED TO ANALYZE THE 4-YEAR EXPERIENCE OF A HIGH-VOLUME CENTER WITH RESPECT TO THE PREVENTION AND MANAGEMENT OF PERIOPERATIVE SLEEVE GASTRECTOMY (LSG) BLEEDING. FROM JUN2012 TO JUN2016, 870 PATIENTS (N=603 FEMALE AND 267 MALE) UNDERWENT LSG. IN THE PROCEDURE, EITHER HARMONIC SCALPEL OR THUNDERBEAT TECHNOLOGY WAS USED IN DISSECTION. GASTRIC RESECTION WAS PERFORMED USING ECHELON FLEX ENDOPATH WITH BLACK, GREEN, YELLOW, AND THEN BLUE CARTRIDGES DEPENDING ON THE THICKNESS. THE FINAL HEMOSTASIS ON THE SUTURE LINE AND GASTROLYSIS WERE ACHIEVED USING HEMOCLIPS, SINGLE STITCHES, AND/OR SURGIFLO. POSTOPERATIVE COMPLICATIONS INCLUDED LEAKS (N=5); MID-GASTRIC STENOSIS (N=3); INTRAABDOMINAL COLLECTION (N=3); BLEEDING (N=17) WHICH WAS TREATED WITH REINTERVENTION (N=9; WITH ONE PATIENT UNDERWENT SPLENECTOMY) AND CONSERVATIVE TREATMENT (N=8; SOURCE OF BLEEDING WERE SUTURE LINE [N=4], GASTROLYSIS [N=3], AND LIVER LACERATION [N=1]), MEAN TRANSFUSION OF 2.1; INFECTED HEMATOMA (N=2) TREATED WITH CT GUIDED DRAINAGE; INFECTED HEMATOMA COMPLICATED BY LATE GASTRIC LEAK WHICH WAS TREATED LAPAROSCOPICALLY WITH LAVAGE AND DRAINAGE; AND SILENT BLEEDING (N=19) CONTROLLED BY USUAL HEMOSTATIC TECHNIQUES. THE EARLY INCIDENCE OF BLEEDING CAN BE ATTRIBUTED TO THE EARLY EXPERIENCE AND THE USE OF BUTTRESSING MATERIAL. THE MAIN STRATEGY FOR MINIMIZING POST-LSG BLEEDING WAS ITS PREVENTION, INCLUDING ADEQUATE PATIENT PREPARATION, USE OF ABSORBABLE BUTTRESSING MATERIAL, ADEQUATE STAPLER CARTRIDGE HEIGHT, AND ADEQUATE REVISION OF HEMOSTASIS BY APPLYING THE INTRAOPERATIVE PROTOCOL FOR THE DETECTION OF SILENT BLEEDING POINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901733 FLEX 60 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention