BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIZUHO NERVE HOOK

    MDR report key: 558638 · Received November 29, 2004

    Report

    Report Number
    558638
    Event Type
    Malfunction
    Date Received
    November 29, 2004
    Date of Event
    November 22, 2004
    Report Date
    November 29, 2004
    Manufacturer
    MIZUHO AMERICA INC
    Product Code
    GDG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    A TRANSNASAL TRANSPHENOIDAL PITUITARY TUMOR REMOVAL WAS IN PROGRESS. A 90 DEGREE MICRO NERVEHOOK WAS USED AND THE SCRUB NURSE NOTICED THAT THE TIP WAS MISSING WHEN IT WAS HANDED BACK. UNDER FLUOROSCOPY THE INSTRUMENT TIP WAS NOT VISIBLE; THE SUCTION FILTER WAS REMOVED AND INSPECTED BUT THE INSTRUMENT TIP WAS NOT FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIZUHO NERVE HOOK MICRO NERVE HOOK GDG MIZUHO AMERICA INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR