BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHOTON HOOK, ANGLED 90 DEGREES BLUNT

    MDR report key: 3207145 · Received June 10, 2013

    Report

    Report Number
    3207145
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 10, 2013
    Manufacturer
    CAREFUSION
    Product Code
    GZX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE TIP OF NERVE HOOK INSTRUMENT BROKE OFF AND FELL INTO THE PATIENT'S HEART DURING A VALVE REPLACEMENT SURGERY. ATTEMPTS TO FIND IT WITH MAGNET UNSUCCESSFUL. X-RAY OF PATIENT DID NOT REVEAL WHERE TIP WAS AT. X-RAY DONE OF CELL SAVER AND HEART BYPASS FILTERS. THE TIP WAS FOUND IN THE CELL SAVER FILTER.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?HEART VALVE REPLACEMENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261760 RHOTON HOOK, ANGLED 90 DEGREES BLUNT INSTRUMENT, MICROSURGICAL GZX CAREFUSION NL3185-010 *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR