BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLASMABLADE 3.0S

    MDR report key: 6216083 · Received December 30, 2016

    Report

    Report Number
    1226420-2016-00208
    Event Type
    Injury
    Date Received
    December 30, 2016
    Date of Event
    November 17, 2016
    Report Date
    December 3, 2016
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K093695
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (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. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING A POST-OPERATIVE VISIT, AFTER A TOTAL MASTECTOMY PROCEDURE, A BURN WAS REPORTED NEAR THE INCISION SITE. IT IS UNKNOWN THE DEGREE OF THE BURN OR IF ANY INTERVENTIONS WERE NEEDED. IT WAS ALSO REPORTED 11 DAYS AFTER THE PROCEDURE THE PATIENT DEVELOPED WOUND NECROSIS AT THE SURGICAL SITE. 18 DAYS POST-OPERATIVE THE NECROSIS APPEARED MORE SEVERE AND THE PATIENT WENT BACK INTO THE OPERATING ROOM TO REMOVE THE NECROTIC TISSUE. NO FURTHER PATIENT INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865884 PLASMABLADE 3.0S ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC PS210-030S FL50938519

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention