BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUAMANTYS BIPOLAR SEALER (UNKNOWN)

    MDR report key: 3253645 · Received July 30, 2013

    Report

    Report Number
    1226420-2013-00144
    Event Type
    Injury
    Date Received
    July 30, 2013
    Date of Event
    June 26, 2013
    Report Date
    July 11, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    DWG
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT #: (B)(4) (METHOD): DEVICE DISCARDED BY FACILITY THEREFORE EVALUATION OF THE DEVICE UNABLE TO BE PERFORMED. (RESULT): DEVICE DISCARDED BY FACILITY THEREFORE EVALUATION OF THE DEVICE UNABLE TO BE PERFORMED. (CONCLUSION): DEVICE DISCARDED BY FACILITY THEREFORE EVALUATION OF THE DEVICE UNABLE TO BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    "BIPOLAR SEALER DEVICE REDUCES BLOOD LOSS AND TRANSFUSION REQUIREMENTS IN POSTERIOR SPINAL FUSION FOR ADOLESCENT IDIOPATHIC SCOLIOSIS" ZACHARY GORDON-MD, JOCHEN SON-HING-MD, CONNIE POE-KOCHERT-CNP, GEORGE THOMPSON-MD PUBLISHED: 6/26/2013 ARTICLE ABSTRACT: HTTP://BIT.LY/18KZ7Q5 PATIENT AGE: 13.9 +/- 1.7 YEARS THEREFORE REPORTED AS AN AVERAGE OF 14 IN MDR REPORT. GENDER: MALE-7 FEMALE-43 THEREFORE REPORTED AS FEMALED IN MDR REPORT DUE TO THE FACT FEMALE REPRESENTED THE MAJORITY WEIGHT: UNKNOWN VIA THE STUDY PERFORMED AND PUBLISHED IN THE ARTICLE THE USE OF THE AQUAMANTYS BIPOLAR SEALER VS. STANDARD ELECTROCAUTERY RESULTED IN A SHORTER OPERATIVE TIME (NOT STATISTICALLY SIGNIFICANT) 310 VA. 343 MINUTES, SIGNIFICANTLY LOWER INTRAOP BLOOD LOSS (STATISTICALLY SIGNIFICANT) (597 VS. 1085 ML), AND SIGNIFICANTLY LESS TOTAL PERIOPERATIVE BLOOD LOSS (STATISTICALLY SIGNIFICANT) (1266 VS 1600ML). ADVERSE EVENTS NOTED IN THE LITERATURE: 1 PATIENT: DEEP POSTOP INFECTION TREATED WITH DEBRIEDMENT AND ANTIBIOTICS 1 PATIENT: PLEURAL EFFUSION 9 PATIENTS: RECEIVED BLOOD TRANSFUSIONS SIGNIFICANTLY HIGHER POSTOP SUCTION DRAINAGE WITH THE USE OF AQUAMANTYS DEVICE VS. STANDARD ELECTROCAUTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354257 AQUAMANTYS BIPOLAR SEALER (UNKNOWN) ELECTROSURGICAL DEVICE DWG MEDTRONIC ADVANCED ENERGY, LLC MAE UNK AQM DEV UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00014 YR Required Intervention