BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGETICS

    MDR report key: 2370261 · Received May 4, 2011

    Report

    Report Number
    1932402-2011-00002
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 11, 2011
    Report Date
    May 2, 2011
    Manufacturer
    SYNERGETICS, INC.
    Product Code
    GEN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ARMS OF THE SPREADER BROKE OFF WHILE BEING USED FOR AN ENDOSCOPIC THIRD VENTRICULOSTOMY. THE PIECE WAS RETRIEVED WITHOUT INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGETICS FORCEPS, PRODUCT CODE: GEN GEN SYNERGETICS, INC. 1030042

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention