BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OAF FIBER

    MDR report key: 9161662 · Received October 7, 2019

    Report

    Report Number
    3004378299-2019-00175
    Event Type
    Malfunction
    Date Received
    October 7, 2019
    Report Date
    November 22, 2019
    Manufacturer
    QUANTA SYSTEM S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K160513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS NOT POSSIBLE TO PERFORM THE INVESTIGATION AND TO DETERMINE THE ROOT CAUSE: THE DEVICE WAS RETURNED IN CONDITION WHICH MADE THE ANALYSIS NOT POSSIBLE. WE ARE UNAWARE ABOUT OPERATOR INJURY.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    THE PROBLEM COULD BE TRACED TO A COMPONENT FAILURE. WE ARE UNAWARE ABOUT OPERATOR INJURY. WE ARE WAITING FOR ADDITIONAL INFORMATION FROM DISTRIBUTOR.

    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
    954714 OAF FIBER SURGICAL OPTICAL FIBER GEX QUANTA SYSTEM S.P.A. OAF002013 E190901

    Patients

    Seq Age Sex Outcome Treatment
    1