BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OAF FIBER

    MDR report key: 8526418 · Received April 18, 2019

    Report

    Report Number
    3004378299-2019-00053
    Event Type
    Malfunction
    Date Received
    April 18, 2019
    Date of Event
    March 13, 2019
    Report Date
    April 18, 2019
    Manufacturer
    QUANTA SYSTEM S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K160513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO IDENTIFY THE ROOT CAUSE, SINCE IT WAS NOT POSSIBLE TO PERFORM A PROPER INVESTIGATION ON THE OPTICAL FIBER. WE ARE UNAWARE ABOUT OPERATOR INJURY.

    Description of Event or Problem · 1

    THE OPTICAL FIBER HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321969 OAF FIBER OPTICAL FIBER GEX QUANTA SYSTEM S.P.A.

    Patients

    Seq Age Sex Outcome Treatment
    1