BEUDAMED
    FDA Adverse Event Death Summary report: N

    EWEND SUCTION RING CURETTE

    MDR report key: 7233663 · Received January 31, 2018

    Report

    Report Number
    MW5074991
    Event Type
    Death
    Date Received
    January 31, 2018
    Date of Event
    January 17, 2018
    Report Date
    January 30, 2018
    Manufacturer
    SYNERGETICS, INC. (N/K/A BAUSCH & LOMB)
    Product Code
    HTF
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    WHILE PT WAS UNDERGOING A TRANSSPHENOIDAL HYPOPHYSECTOMY FOR A PITUITARY TUMOR, THE RING CURETTE INSTRUMENT BROKE APART IN THE PT'S NASAL CAVITY/BRAIN TISSUE. THE END OF THE CURETTE SEPARATED FROM THE HANDLE AT THE DISTAL ATTACHMENT. THE INSTRUMENT WAS REMOVED, BUT THE PT SUSTAINED A CEREBROVASCULAR EVENT. PT WAS INTUBATED WITH POOR PROGNOSIS UNTIL CARE WITHDRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73457 EWEND SUCTION RING CURETTE SURGICAL INSTRUMENT HTF SYNERGETICS, INC. (N/K/A BAUSCH & LOMB) N090D5.0-160

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death