BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUSTRIGHT SEALER

    MDR report key: 6221068 · Received January 4, 2017

    Report

    Report Number
    6221068
    Event Type
    Malfunction
    Date Received
    January 4, 2017
    Date of Event
    December 22, 2016
    Report Date
    January 3, 2017
    Manufacturer
    JUSTRIGHT SURGICAL, LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    JUSTRIGHT SEALER, LOT #75CF1604, WAS USED DURING THIS THORACOSCOPIC CASE. AFTER REPEATED USE OF OPENING AND CLOSING THE JAWS OF THE SEALER, THE HINGE BECAME WIDENED AND WOULD NOT PASS THROUGH THE TROCAR. NO PATIENT HARM WAS NOTED. A NEW SEALER WAS OPENED TO CONTINUE THE CASE.

    Description of Event or Problem · 1

    JUSTRIGHT SEALER, LOT #75CF1604, WAS USED DURING THIS THORACOSCOPIC CASE. AFTER REPEATED USE OF OPENING AND CLOSING THE JAWS OF THE SEALER, THE HINGE BECAME WIDENED AND WOULD NOT PASS THROUGH THE TROCAR. NO PATIENT HARM WAS NOTED. A NEW SEALER WAS OPENED TO CONTINUE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4139 JUSTRIGHT SEALER ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI JUSTRIGHT SURGICAL, LLC JR-SE20 75CF1604

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR