BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OAF FIBER

    MDR report key: 8136679 · Received December 6, 2018

    Report

    Report Number
    3004378299-2018-00141
    Event Type
    Malfunction
    Date Received
    December 6, 2018
    Date of Event
    November 7, 2018
    Report Date
    November 18, 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 DETERMINE THE ROOT CAUSE SINCE NO INSPECTION POSSIBLE; FIBER RETURNED NOT STERILIZED. WE ARE UNAWARE ABOUT PATIENT INJURY.

    Description of Event or Problem · 0

    THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

    Additional Manufacturer Narrative · 1

    THE PROBLEM WAS DUE TO A COMPONENT FAILURE. WE ARE UNAWARE ABOUT PATIENT INJURY. WE ARE WAITING FOR ADDITIONAL INFORMATION FROM THE DISTRIBUTOR.

    Description of Event or Problem · 1

    THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979949 OAF FIBER SURGICAL OPTICAL FIBER GEX QUANTA SYSTEM S.P.A.

    Patients

    Seq Age Sex Outcome Treatment
    1