BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EEA

    MDR report key: 12915883 · Received December 2, 2021

    Report

    Report Number
    2647580-2021-04089
    Event Type
    Injury
    Date Received
    December 2, 2021
    Date of Event
    March 5, 2021
    Report Date
    December 2, 2021
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: EVALUATION OF FIBRIN SEALANT IN PREVENTION OF CERVICAL ANASTOMOTIC LEAKAGE AFTER MCKEOWN ESOPHAGECTOMY: A SINGLE CENTER, RETROSPECTIVE STUDY SOURCE: ANN SURG ONCOL (2021) 28:6390¿6397. PUBLISHED ONLINE: 30 MARCH 2021. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY ANALYZED OUTCOMES OF PATIENTS WITH ESOPHAGEAL CANCER WHO UNDERWENT MCKEOWN ESOPHAGECTOMY WITH AND WITHOUT FIBRIN SEALANT APPLICATION BETWEEN JANUARY 2018 AND DECEMBER 2019. THE STOMACH WAS ANASTOMOSED TO THE ESOPHAGUS WITH A CIRCULAR STAPLER WAS USED TO ANASTOMOSE THE ESOPHAGUS AND THE STOMACH. A LINEAR STAPLER OR ANOTHER COMPETITOR STAPLER WAS USED TO CLOSE THE GASTRIC TUBE. THERE WERE 227 PATIENTS IN THE STUDY AND POSTOPERATIVE COMPLICATIONS INCLUDED: ANASTOMOTIC LEAK, ANASTOMOTIC STRICTURE AND GASTRIC FISTULA. PATIENTS WITH ANASTOMOTIC LEAK WERE TREATED WITH CERVICAL DRAINAGE AND ENDOSCOPIC TREATMENT. GASTRIC FISTULA WAS DIAGNOSED WITH ESOPHAGOGASTRODUODENOSCOPY (EGD). HOSPITAL STAY WAS EXTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1813952 UNKNOWN EEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN EEA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H