BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR SEALER AQM MBS W/LIGHT

    MDR report key: 3438531 · Received October 30, 2013

    Report

    Report Number
    1226420-2013-00178
    Event Type
    Malfunction
    Date Received
    October 30, 2013
    Date of Event
    September 24, 2013
    Report Date
    October 1, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    DWG
    PMA / PMN Number
    K073495
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD, RESULTS, CONCLUSION: FACILITY DISPOSED OF DEVICE. DEVICE IS NOT AVAILABLE FOR RETURN AND INSPECTION. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE AQUAMANTYS WAS USED IN TWO SPINE CASES, ONE ON (B)(6) WITH AN EVS USED ONE DAY AND AN MBS USED THE OTHER. IT IS UNKNOWN WHICH DEVICE CORRESPONDS WITH THESE DATES. THE CASES WERE SUCCESSFUL WITH NO PRODUCT OR PERFORMANCE ISSUES. SUBSEQUENT TO THE CASES, THE DOCTOR NOTICED MORE CLEAR DRAIN OUTPUT FROM THE PATIENTS, WHICH THE DOCTOR FELT MAY BE DUE TO THE AQUAMANTYS. THE PATIENTS HAVE NOT HAD ANY POST-SURGERY COMPLICATIONS OR MEDICAL OR SURGICAL INTERVENTIONS. DOCTOR REFUSES TO PROVIDE ANY PATIENT INFORMATION AS HE IS NOT CONCERNED ABOUT THESE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558272 BIPOLAR SEALER AQM MBS W/LIGHT ELECTROSURGICAL DEVICE DWG MEDTRONIC ADVANCED ENERGY, LLC 23-301-1 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1