BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O.R. CAMERA COVER ADAPTOR FOR BERCHTOLD NON-STERILE

    MDR report key: 3345710 · Received August 8, 2013

    Report

    Report Number
    1836161-2013-00135
    Event Type
    Malfunction
    Date Received
    August 8, 2013
    Date of Event
    July 31, 2013
    Report Date
    August 8, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    FTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REMOVED ADAPTER TO WORK ON THE CAMERA. THE ASPEN ADAPTER HAS 3 FIXED SCREWS THAT SITS IN A GROVE ON THE HOUSING OF THE BERCHTOLD CAMERA. THE ENTIRE CAMERA, INCLUDING THE GROOVE, IS BLACK. HOWEVER WHEN THE ENGINEERING REMOVED THE ADAPTER AND THE CAMERA, THE GROVE WAS ENTIRELY SHAVED DOWN TO THE METAL FROM THE ADAPTER CONTINUOUSLY BEING TURNED BY STAFF MEMBERS. THE ENGINEER IS CONCERNED THAT THE BLACK SHAVING FROM THE COATING OF THE CAMERA IS COMING LOOSE AND COULD POSSIBLY CONTAMINATE THE FIELD/FALL INTO A PT DURING A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375114 O.R. CAMERA COVER ADAPTOR FOR BERCHTOLD NON-STERILE LIGHT HANDLE FTA ASPEN SURGICAL PRODUCTS, INC. LT-9902

    Patients

    Seq Age Sex Outcome Treatment
    1