BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUAMANTYS 9.5XL BIPOLAR SEALER

    MDR report key: 3233526 · Received July 18, 2013

    Report

    Report Number
    1226420-2013-00132
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    January 4, 2012
    Report Date
    June 19, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    DWG
    PMA / PMN Number
    K101057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (B)(4), EVALUATION METHOD: DEVICE NOT RETURNED TO MANUFACTURER THEREFORE ANALYSIS COULD NOT BE PERFORMED. EVALUATION RESULT: DEVICE NOT RETURNED TO MANUFACTURER THEREFORE ANALYSIS COULD NOT BE PERFORMED. EVALUATION CONCLUSION: DEVICE NOT RETURNED TO MANUFACTURER THEREFORE ANALYSIS COULD NOT BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    LITERATURE: (ANIMAL) STUDY WAS PRESENTED IN PART AT THE ANNUAL SCIENTIFIC MEETING OF THE SOCIETY OF ACADEMIC AND RESEARCH SURGERY, 4¿5 JANUARY 2012, NOTTINGHAM AND HAS BEEN PUBLISHED IN ABSTRACT FORM [BR J SURG 2012; 99 (SUPPL. 4): 31]. THE AIM OF THE STUDY WAS TO DEFINE THE EXTENT OF PARENCHYMAL ABLATION AND TISSUE NECROSIS ACHIEVED USING ABLATIVE TECHNIQUES IN A NON-PERFUSED BENCHTOP CADAVERIC MODEL. TISSUE ABLATION AND NECROSIS WAS MEASURED FOR EACH OF THE ABLATIVE METHODS UTILIZED. THE AQUAMANTYS DEVICE PRODUCED A WIDE BAND OF COAGULATION ADJACENT TO THE LINE OF TRANSECTION, BUT THIS WAS NOT REFLECTED IN EITHER THE ABLATIVE OR NECROTIC BAND WIDTH. ALTHOUGH THE DEVICE LED TO DISRUPTION OF THE EXTRACELLULAR MATRIX WITHIN THIS COAGULATIVE BAND TO A DISTANCE OF 2 MM FROM THE RESECTION MARGIN, THERE WAS NO CLEAR EVIDENCE OF TISSUE NECROSIS BEYOND 1 MM. THE IMPACT OF THIS COAGULATION EFFECT ON TUMOUR CELL VIABILITY IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336410 AQUAMANTYS 9.5XL BIPOLAR SEALER ELECTROSURGICAL DEVICE DWG MEDTRONIC ADVANCED ENERGY, LLC 23-313-1 UKNNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1