BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA

    MDR report key: 13089664 · Received December 27, 2021

    Report

    Report Number
    1219930-2021-05342
    Event Type
    Injury
    Date Received
    December 27, 2021
    Date of Event
    December 6, 2020
    Report Date
    December 27, 2021
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884523003154
    PMA / PMN Number
    K111825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: BRIDGED ONE-ANASTOMOSIS GASTRIC BYPASS: TECHNIQUE AND PRELIMINARY RESULTS SOURCE: SURGERY TODAY (2021) 51:1371¿1378. 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 WHO UNDERWENT ONE-ANASTOMOSIS GASTRIC BYPASS SURGERY BETWEEN SEPTEMBER 2018 AND NOVEMBER 2020. A 45 MM PURPLE RELOAD WAS USED TO TRANSECT THE STOMACH AND TO PERFORM THE GASTROJEJUNAL ANASTOMOSIS. THERE WERE 44 PATIENTS IN THE STUDY AND POSTOPERATIVE COMPLICATIONS INCLUDED: ANASTOMOTIC STENOSIS, STAPLE LINE HEMATOMA AND ANASTOMOTIC ULCER. ENDOSCOPIC INTERVENTION WAS REQUIRED FOR STENOSIS AND THE HEMATOMA. THE PATIENT WITH THE ULCER WAS READMITTED AND TREATED WITH MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1987494 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIA45AMT 10884523003154

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H