BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBB ELEVATOR

    MDR report key: 3915343 · Received June 5, 2014

    Report

    Report Number
    3915343
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    March 21, 2014
    Report Date
    June 3, 2014
    Manufacturer
    SYMMETRY SURGICAL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    TOWARDS THE END OF THE CASE, THE SURGICAL TECHNOLOGIST WAS CLEANING A COBB ELEVATOR THAT HAD BEEN USED THROUGHOUT THE CASE AND HE DISCOVERED THAT THE WORKING END OF THE COBB WAS LOOSE FROM THE HANDLE END. HE NOTICED THERE WAS "RESIDUE" INSIDE THE THREADING WHERE THE PIECES COME TOGTHER. WE ARE NOT SURE IF THIS IS FROM OUR PATIENT OR A PREVIOUS PATIENT. THE COBB WAS PASSED OFF OF THE FIELD, HOWEVER IT HAD ALREADY BEEN USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328877 COBB ELEVATOR ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY LXH SYMMETRY SURGICAL 65-2547 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR