BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUAMANTYS 6.0 BIPOLAR SEALER

    MDR report key: 2062604 · Received April 8, 2011

    Report

    Report Number
    1226420-2011-00006
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    March 11, 2011
    Report Date
    April 8, 2011
    Manufacturer
    SALIENT SURGICAL TECHNOLOGIES, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR HAS MADE SEVERAL ATTEMPTS TO OBTAIN INFO FROM THE SURGEON TO EVALUATE COMPLAINT. REPORT WILL BE UPDATED IF ADD'L INFO IS OBTAINED.

    Description of Event or Problem · 1

    SALIENT OBTAINED A REPORT THAT THERE WAS A PT SIDE EFFECT. THE PROCEDURE WAS A TOTAL KNEE REPLACEMENT USING THE AQUAMANTYS 6.0 DEVICE. THE PT DEVELOPED PERONEAL NERVE PALSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUAMANTYS 6.0 BIPOLAR SEALER AQUAMANTYS 6.0 BIPOLAR SEALER GEI SALIENT SURGICAL TECHNOLOGIES, INC. 23-112-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other