BEUDAMED
    FDA Adverse Event Other Summary report: N

    FEMTO LDV Z4

    MDR report key: 3817531 · Received May 9, 2014

    Report

    Report Number
    3005643720-2014-00020
    Event Type
    Other
    Date Received
    May 9, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 17, 2014
    Manufacturer
    SIE AG, SURGICAL INSTRUMENT ENGINEERING
    Product Code
    GEX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE BUILD UP OF THE VACUUM WAS NOT POSSIBLE. THE OPERATION WAS ABORTED. NO CUT WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282053 FEMTO LDV Z4 FEMTO LDV Z4 GEX SIE AG, SURGICAL INSTRUMENT ENGINEERING Z4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1