BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 11979728 · Received June 10, 2021

    Report

    Report Number
    1219930-2021-02305
    Event Type
    Injury
    Date Received
    June 10, 2021
    Date of Event
    July 19, 2020
    Report Date
    June 10, 2021
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: MARGIN-POSITIVE PANCREATIC DUCTAL ADENOCARCINOMA DURING PANCREATICODUODENECTOMY: ADDITIONAL RESECTION DOES NOT IMPROVE SURVIVAL SOURCE: ANN SURGONCOL (2021) 28:1552¿1562 HTTPS://DOI.ORG/10.1245/S10434-020-09000-9. 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 2006 AND 2015, A STUDY ANALYZED OUTCOMES OF PATIENTS WHO UNDERWENT PANCREATICODUODENECTOMY FOR PANCREATIC DUCTAL ADENOCARCINOMA. THE STAPLER WAS USED TO DIVIDE THE DUODENUM. THERE WERE 501 PATIENTS IN THE STUDY AND COMPLICATIONS INCLUDED: POSTOPERATIVE HEMORRHAGE, PANCREATIC FISTULA. READMISSIONS WERE REPORTED BUT NO OTHER INTERVENTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872056 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| O