BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OFH FIBER

    MDR report key: 8402789 · Received March 8, 2019

    Report

    Report Number
    3004378299-2019-00030
    Event Type
    Malfunction
    Date Received
    March 8, 2019
    Date of Event
    February 8, 2019
    Report Date
    November 19, 2019
    Manufacturer
    QUANTA SYSTEM S.P.A.
    Product Code
    GEX
    UDI-DI
    08033945937973
    PMA / PMN Number
    K180158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE SINCE THE DEVICE WAS DISCARDED. WE ARE UNAWARE ABOUT OPERATOR INJURY.

    Description of Event or Problem · 0

    THE SINGLE USE OPTICAL FIBER 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 OPERATOR INJURY. WE ARE WAITING FOR ADDITIONAL INFORMATION FROM THE DISTRIBUTOR.

    Description of Event or Problem · 1

    THE SINGLE USE OPTICAL FIBER 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
    197465 OFH FIBER OPTICAL LASER FIBER GEX QUANTA SYSTEM S.P.A. H184512 08033945937973

    Patients

    Seq Age Sex Outcome Treatment
    1