BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLASMABLADE 3.0S

    MDR report key: 6027890 · Received October 13, 2016

    Report

    Report Number
    1226420-2016-00155
    Event Type
    Injury
    Date Received
    October 13, 2016
    Date of Event
    September 14, 2016
    Report Date
    October 14, 2016
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K093695
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT INFORMATION INCOMPLETE AND MISSING PATIENT INFORMATION UNABLE TO BE OBTAINED DESPITE A GOOD FAITH EFFORT MADE TO OBTAIN THE INFORMATION FROM THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    (B)(4) 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

    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 POST-OPERATIVE CARE, STAFF REPORTED A BURN ON THE PATIENTS LEFT HIP. THE CAUSE OF THE BURN IS UNKNOWN. THE SURGEON REPORTED IT WAS NEAR THE SITE OF THE RETURN PAD, BUT IT IS UNKNOWN IF THE PAD CONTRIBUTED TO THE BURN. NO FURTHER DETAILS WERE REPORTED ABOUT THE SEVERITY OF THE BURN OR INTERVENTIONS NEEDED. ADDITIONAL INFORMATION AND SOME PATIENT DEMOGRAPHICS RECEIVED. THE SIZE OF THE BURN WAS APPROXIMATELY 2CM X 4CM. THE SEVERITY WAS AS FULL THICKNESS BURN THAT WAS TREATED WITH WOUND CARE FOLLOW-UP. NO OTHER DETAILS EXPECTED AT THIS TIME.

    Description of Event or Problem · 1

    DURING POST-OPERATIVE CARE, STAFF REPORTED A BURN ON THE PATIENTS LEFT HIP. THE CAUSE OF THE BURN IS UNKNOWN. THE SURGEON REPORTED IT WAS NEAR THE SITE OF THE RETURN PAD, BUT IT IS UNKNOWN IF THE PAD CONTRIBUTED TO THE BURN. NO FURTHER DETAILS WERE REPORTED ABOUT THE SEVERITY OF THE BURN OR INTERVENTIONS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679911 PLASMABLADE 3.0S ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC PS210-030S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR