BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EEA

    MDR report key: 11913667 · Received June 1, 2021

    Report

    Report Number
    2647580-2021-01839
    Event Type
    Injury
    Date Received
    June 1, 2021
    Date of Event
    October 8, 2020
    Report Date
    June 1, 2021
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: CLINICAL AND ONCOLOGICAL OUTCOMES OF THE LOW LIGATION OF THE INFERIOR MESENTERIC ARTERY WITH ROBOTIC SURGERY IN PATIENTS WITH RECTAL CANCER FOLLOWING NEOADJUVANT CHEMORADIOTHERAPY. SOURCE: TURK J MED SCI (2021) 51: 111-123 PUBLISHED ONLINE: 10.08.2020. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED JANUARY 2014 AND JANUARY 2018, A RETROSPECTIVE STUDY ANALYZED POSTOPERATIVE COMPLICATIONS OF 77 PATIENTS WITH RECTAL CANCER WHO UNDERWENT ROBOTIC SURGERY WITH THE HIGH LIGATION AND LOW LIGATION OF THE INFERIOR MESENTERIC ARTERY. THERE WERE 38 PATIENTS IN THE LOW LIGATION GROUP AND 39 IN THE HIGH LIGATION GROUP. A CIRCULAR STAPLER WAS USED FOR END-TO-END COLORECTAL ANASTOMOSIS. POSTOPERATIVE COMPLICATIONS INCLUDED: ANASTOMOSIS LEAK, ANASTOMOTIC STRICTURE, RECTOVAGINAL FISTULA, SURGICAL SITE INFECTION, AND POSTOPERATIVE BLEEDING. ANASTOMOTIC STRICTURE WAS TREATED WITH COLONOSCOPIC BALLOON DILATATION, DIGITAL DILATATION, AND SURGICAL INTERVENTION (RESULTING IN 3 PATIENTS WITH COLOSTOMY). RECTOVAGINAL FISTULAS REQUIRED SURGICAL INTERVENTION. ANASTOMOSIS LEAKAGE REQUIRED SURGICAL INTERVENTION FOR SUTURING OR COLOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812834 UNKNOWN EEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN EEA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention