BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOLDER SURGICAL JUSTRIGHT STAPLER 5MM

    MDR report key: 12210747 · Received July 21, 2021

    Report

    Report Number
    MW5102691
    Event Type
    Injury
    Date Received
    July 21, 2021
    Date of Event
    July 6, 2021
    Report Date
    July 15, 2021
    Manufacturer
    BOLDER SURGICAL LLC
    Product Code
    GAG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE BOLDER SURGICAL JUSTRIGHT 5MM STAPLER MISFIRED DURING A LAPAROSCOPIC PROCEDURE RESULTING IN CONVERSION TO AN OPEN PROCEDURE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104791 BOLDER SURGICAL JUSTRIGHT STAPLER 5MM STAPLER, SURGICAL GAG BOLDER SURGICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other