BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVIDIEN ENDO GIA STAPLER

    MDR report key: 12672485 · Received October 20, 2021

    Report

    Report Number
    MW5104812
    Event Type
    Injury
    Date Received
    October 20, 2021
    Date of Event
    October 5, 2021
    Report Date
    October 18, 2021
    Manufacturer
    MEDTRONIC / COVIDIEN
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    COVIDIEN ENDO GIA STAPLER USED IN A ROBOTIC ASSISTED RIGHT COLON RESECTION. WHILE HE WAS REMOVING THE SPECIMEN, HE NOTICED BLEEDING AROUND THE AREA HE JUST STAPLED AND FOUND OUT THAT THE STAPLE FAILED. SURGEON HAD TO USE THE SILK SUTURE TO CLOSE THE ARTERY SINCE IT WAS WIDE OPEN AND STAPLE LINE WAS GONE. AFTER THE REPAIR WITH SUTURES HE PROCEEDED WITH THE CASE AND CLOSED THE ABDOMEN WITH NO ISSUES. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566877 COVIDIEN ENDO GIA STAPLER STAPLE, IMPLANTABLE GDW MEDTRONIC / COVIDIEN EGIA45AV N1F0241Y

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention