BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OAF FIBER

    MDR report key: 8767123 · Received July 8, 2019

    Report

    Report Number
    3004378299-2019-00096
    Event Type
    Malfunction
    Date Received
    July 8, 2019
    Date of Event
    June 7, 2019
    Report Date
    July 8, 2019
    Manufacturer
    QUANTA SYSTEM S.P.A.
    Product Code
    GEX
    UDI-DI
    08033945933487
    PMA / PMN Number
    K131473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS IMPOSSIBLE TO DETERMINE THE PROBLEM ROOT CAUSE SINCE THE PRODUCT WAS RECEIVED NOT STERILE AND AS A CONSEQUENCE IT COULD NOT BE HANDLED BY OUR OPERATORS. 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
    560195 OAF FIBER SURGICAL OPTICAL FIBER GEX QUANTA SYSTEM S.P.A. OAF002011 A181000 08033945933487

    Patients

    Seq Age Sex Outcome Treatment
    1