BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN ENDO GIA INSTRUMENT

    MDR report key: 10788722 · Received November 4, 2020

    Report

    Report Number
    2647580-2020-03696
    Event Type
    Death
    Date Received
    November 4, 2020
    Date of Event
    July 21, 2020
    Report Date
    November 4, 2020
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: COMPARISON OF END-TO-SIDE HAND-SEWN AND SIDE-TO-SIDE STAPLED CERVICAL ESOPHAGOGASTRIC ANASTOMOSIS IN PATIENTS WITH LOWER THORACIC ESOPHAGEAL CANCER UNDERGOING TRANSHIATAL ESOPHAGECTOMY: AN IRANIAN RETROSPECTIVE COHORT STUDY SOURCE: RASIHASHEMI ET AL. BMC GASTROENTEROLOGY (2020) 20:250 PAGES 1-9, PUBLISHED ONLINE: 07.31.2020. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, THIS STUDY COMPARED THE CLINICAL OUTCOMES OF HAND-SEWN END-TO-SIDE ESOPHAGO-GASTROSTOMY AND SIDE-TO-SIDE STAPLED CERVICAL ESOPHAGOGASTRIC ANASTOMOSIS AFTER ESOPHAGECTOMY. IT WAS REPORTED THAT THERE WAS A TOTAL OF 433 PATIENTS WHO UNDERWENT TRANSHIATAL ESOPHAGECTOMY FOR ESOPHAGEAL CANCER AT A HOSPITAL IN IRAN BETWEEN 2010 AND 2016. ALL THE PATIENTS WERE OPERATED USING HAND-SEWN ESOPHAGO-GASTROSTOMY OR STAPLED CERVICAL ESOPHAGOGASTRIC ANASTOMOSIS. HAND-SEWN ANASTOMOSIS WAS CARRIED OUT IN 271 PATIENTS, AND STAPLED ANASTOMOSIS WAS PERFORMED IN 162 PATIENTS. IN THE STAPLED ANASTOMOSIS, MANUAL STAPLER WAS USED TOGETHER WITH A BLUE RELOAD TO PERFORM ANASTOMOSIS OF THE POSTERIOR WALL OF THE ESOPHAGUS TO THE POSTERIOR WALL OF THE GASTRIC CONDUIT. POST-OPERATIVE COMPLICATIONS IN THE STAPLED ANASTOMOSIS GROUP INCLUDED: 5 DEATHS (4 HOSPITAL DEATHS AND 1 30-DAYS, ONE DEATH DUE TO ANASTOMOTIC LEAK). COMPARISON OF END-TO-SIDE HAND-SEWN AND SIDE-TO-SIDE STAPLED CERVICAL ESOPHAGOGASTRIC ANASTOMOSIS IN PATIENTS WITH LOWER THORACIC ESOPHAGEAL CANCER UNDERGOING TRANSHIATAL ESOPHAGECTOMY: AN IRANIAN RET; BMC GASTROENTEROLOGY; 2020; SEYED ZIAEDDIN RASIHASHEMI, ALI RAMOUZ, HASSAN AMINI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248278 UNKNOWN ENDO GIA INSTRUMENT STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN ENDO GIA INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R