BEUDAMED
    FDA Adverse Event Summary report: N

    SUGITA

    MDR report key: 2466843 · Received February 7, 2012

    Report

    Report Number
    2466843
    Date Received
    February 7, 2012
    Date of Event
    October 19, 2011
    Report Date
    February 7, 2012
    Manufacturer
    MIZUHO AMERICA INC.
    Product Code
    GZT
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    A SMALL PIECE OF THE SUGITA RETRACTOR BROKE (A HOOK) DURING SURGERY WHILE THE DR WAS PLACING NEAR THE SURGICAL INCISION. BOTH PIECES WERE RETRIEVED AND HANDED OFF THE FIELD. X-RAY OF PATIENT'S HEAD WAS DONE BEFORE CLOSURE TO ENSURE THAT NO PIECES WERE LEFT BEHIND. READ NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUGITA RETRACTOR, NEUROSURGICAL GZT MIZUHO AMERICA INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR