BEUDAMED
    FDA Adverse Event Summary report: N

    SURGITA ANEURYSM CLIP

    MDR report key: 42470 · Received October 3, 1996

    Report

    Report Number
    42470
    Date Received
    October 3, 1996
    Date of Event
    September 4, 1996
    Report Date
    September 20, 1996
    Manufacturer
    MIZUHO AMERICA, INC.
    Product Code
    DSS
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    9/4/96 RIGHT FRONTAL CRANEOTOMY AND CLIPPING OF ANEURYSM. 9/5/96 POST-OP ANGIO, SLIPPED CLIP. PT RETURNED TO OR 9/6/96 FOR REPEAT CLIPPING. NEUROSURGEON UNABLE TO DETERMINE IF CLIP IS DEFECTIVE OR PRESSURE CAUSED CLIP TO SLIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITA ANEURYSM CLIP Implant CLIP DSS MIZUHO AMERICA, INC. * T8-4

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR 6MM SURGITA ANEURYSM CLIP