BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUST RIGHT 5MM STAPLER 12 MM

    MDR report key: 10546271 · Received September 16, 2020

    Report

    Report Number
    MW5096700
    Event Type
    Malfunction
    Date Received
    September 16, 2020
    Date of Event
    August 9, 2020
    Report Date
    September 14, 2020
    Manufacturer
    JUSTRIGHT SURGICAL / BOLDER SURGICAL, LLC
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STAPLE LINE DID NOT SEAL WHEN USING FOR APPY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003767 JUST RIGHT 5MM STAPLER 12 MM STAPLER, SURGICAL GAG JUSTRIGHT SURGICAL / BOLDER SURGICAL, LLC 00865163000102 75BJ1305

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR