BEUDAMED
    FDA Adverse Event Other Summary report: N

    FEMTO LDV Z4

    MDR report key: 3884029 · Received June 13, 2014

    Report

    Report Number
    3005643720-2014-00024
    Event Type
    Other
    Date Received
    June 13, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 11, 2014
    Manufacturer
    SURGICAL INSTRUMENT ENGINEERING AG
    Product Code
    OOE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITUATION OF A PSEUDO SUCTION WAS EXPLAINED TO THE NURSE AND THE RESULT OF THE FLAP SUPPORTED THE POSSIBILITY OF THE PSEUDO SUCTION.

    Description of Event or Problem · 1

    THE RESULTING FLAP WAS SMALLER THAN EXPECTED AND DID NOT SHOW A HINGE. THE RESULTING FLAP COULD NOT BE OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351073 FEMTO LDV Z4 FEMTO LDV Z4 OOE SURGICAL INSTRUMENT ENGINEERING AG Z4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other