BEUDAMED
    FDA Adverse Event Other Summary report: N

    FEMTO LDV Z2

    MDR report key: 3767720 · Received April 16, 2014

    Report

    Report Number
    3005643720-2014-00017
    Event Type
    Other
    Date Received
    April 16, 2014
    Date of Event
    March 25, 2014
    Report Date
    April 9, 2014
    Manufacturer
    SIE AG SURGICAL INSTRUMENT ENGINEERING
    Product Code
    GEX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE RESULTING FLAP WAS DECENTRED. THE DOCTOR DID NOT PERFORM THE SURGERY BUT ABORTED. HE WILL RE-TREAT THE PT AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233863 FEMTO LDV Z2 FEMTO LDV Z2 GEX SIE AG SURGICAL INSTRUMENT ENGINEERING Z2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other