BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR SEALER AQM MBS W/LIGHT

    MDR report key: 5315340 · Received December 21, 2015

    Report

    Report Number
    1226420-2015-00194
    Event Type
    Malfunction
    Date Received
    December 21, 2015
    Date of Event
    December 4, 2015
    Report Date
    December 4, 2015
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K073495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) PATIENT INFORMATION UNABLE TO BE OBTAINED AS CUSTOMER CONTACT REFUSED TO PROVIDE REQUESTED INFORMATION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AFTER COMPLETION OF A SURGICAL PROCEDURE, IT WAS IDENTIFIED THAT THE MALLEABLE BIPOLAR SEALER DEVICE UTILIZED WAS AN EXPIRED DEVICE. THERE WAS NO REPORTED PATIENT IMPACT. CUSTOMER DISCARDED THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842130 BIPOLAR SEALER AQM MBS W/LIGHT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC 23-301-1 PHK214A0

    Patients

    Seq Age Sex Outcome Treatment
    1