BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLASMABLADE 3.0S

    MDR report key: 7101031 · Received December 8, 2017

    Report

    Report Number
    1226420-2017-00312
    Event Type
    Injury
    Date Received
    December 8, 2017
    Date of Event
    November 10, 2017
    Report Date
    December 8, 2017
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K093695
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PATIENT INFORMATION INCOMPLETE AND MISSING PATIENT INFORMATION UNABLE TO BE OBTAINED DESPITE A GOOD FAITH EFFORT MADE TO OBTAIN THE INFORMATION FROM THE CUSTOMER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    POST-OPERATIVELY, THE PATIENT DEVELOPED A HEMATOMA AROUND THE CHEST WALL. THE PATIENT RECEIVED A TRANSFUSION OF 3 UNITS OF BLOOD AND 2 UNITS OF FFP. THE SURGEON DOES NOT BELIEVE THE PLASMABLADE DEVICE CONTRIBUTED TO THE INJURY, HOWEVER COULD NOT RULE IT OUT COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880196 PLASMABLADE 3.0S ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC PS210-030S 0213356483

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention