BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O.R. CAMERA COVER ADAPTOR FOR SKYTRON

    MDR report key: 5704064 · Received June 7, 2016

    Report

    Report Number
    1836161-2016-00049
    Event Type
    Malfunction
    Date Received
    June 7, 2016
    Date of Event
    May 9, 2016
    Report Date
    May 9, 2016
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    FTA
    PMA / PMN Number
    K020304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER IS STATING THAT THE CAMERA COVER DOES NOT THREAD PROPERLY ONTO THE ADAPTOR AND THAT A CAMERA COVER FELL OFF OF THE ADAPTOR DURING A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359495 O.R. CAMERA COVER ADAPTOR FOR SKYTRON O.R. CAMERA COVER ADAPTOR FTA ASPEN SURGICAL PRODUCTS, CALEDONIA LT-9900

    Patients

    Seq Age Sex Outcome Treatment
    1