BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUAMANTYS GENERATOR (115V)

    MDR report key: 6925803 · Received October 6, 2017

    Report

    Report Number
    1226420-2017-00247
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    September 7, 2017
    Report Date
    October 4, 2018
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052859
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BRIEF DESCRIPTION OF COMPLAINT: A 6.0 DEVICE WAS BEING USED TO PROACTIVELY TREAT THE PRESCRIBED AREAS AND CONTINUOUS SUCTION WAS BEING USED; HOWEVER, SOME OF THE HEATED SALINE WAS ABLE TO GET PAST THE SUCTION. THE SALINE RAN DOWN THE PATIENT¿S LEG, RESULTING IN A BURN TO THE UPPER TWO THIRDS OF THE RIGHT MOST ANTERIOR SHIN. INVESTIGATION CONCLUSION: THE REPORTED ISSUE WAS NOT CONFIRMED. GENERATOR PASSES ALL FUNCTIONAL, PRIME, SALINE FLOW, AND POWER OUTPUT TESTS. THERE ARE NO FAILURES FOUND AND THE PATIENT INJURY ALLEGATION CANNOT BE REPLICATED IN THE LABORATORY ENVIRONMENT. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (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.

    Description of Event or Problem · 1

    DURING AN ORTHO CASE, WHILE USING SUCTION, HEATED SALINE FROM THE AQUAMANTYS DEVICE RAN OFF ONTO THE PATIENT¿S LEG RESULTING IN A BURN. THE BURN WAS APPROXIMATELY 4 INCHES LONG, THE DEGREE IS UNKNOWN. THE BURN WAS TREATED WITH AN ANTIMICROBIAL DRESSING.

    Description of Event or Problem · 1

    DURING AN ORTHO CASE, WHILE USING SUCTION, HEATED SALINE FROM THE AQUAMANTYS DEVICE RAN OFF ONTO THE PATIENT¿S LEG RESULTING IN A BURN. THE BURN WAS APPROXIMATELY 4 INCHES LONG, THE DEGREE IS UNKNOWN. THE BURN WAS TREATED WITH AN ANTIMICROBIAL DRESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700489 AQUAMANTYS GENERATOR (115V) ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC 40-402-1

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention