BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUSTRIGHT SEALER

    MDR report key: 11744467 · Received April 29, 2021

    Report

    Report Number
    11744467
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    March 16, 2021
    Report Date
    March 22, 2021
    Manufacturer
    JUSTRIGHT SURGICAL, LLC
    Product Code
    GEI
    UDI-DI
    00865163000126
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEVICE STOPPED WORKING. DID NOT SEAL TISSUE. MANUFACTURER RESPONSE FOR ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES, JUST RIGHT SEALER (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644487 JUSTRIGHT SEALER ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES GEI JUSTRIGHT SURGICAL, LLC JR-SE20 75DJ0717 00865163000126

    Patients

    Seq Age Sex Outcome Treatment
    1