BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OFH FIBER

    MDR report key: 8343341 · Received February 15, 2019

    Report

    Report Number
    3004378299-2019-00012
    Event Type
    Malfunction
    Date Received
    February 15, 2019
    Date of Event
    December 3, 2018
    Report Date
    November 19, 2019
    Manufacturer
    QUANTA SYSTEM S.P.A.
    Product Code
    GEX
    UDI-DI
    08033945938093
    PMA / PMN Number
    K180158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROBLEM COULD BE TRACED TO A COMPONENT FAILURE WHICH COULD BE RELATED TO A POTENTIAL MISHANDLING DURING REPROCESSING. WE ARE UNAWARE ABOUT PATIENT INJURY.

    Description of Event or Problem · 0

    THE 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 PATIENT INJURY. WE ARE WAITING FOR ADDITIONAL INFORMATION FROM THE DISTRIBUTOR.

    Description of Event or Problem · 1

    THE 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
    138877 OFH FIBER SURGICAL LASER FIBER GEX QUANTA SYSTEM S.P.A. H182810 08033945938093

    Patients

    Seq Age Sex Outcome Treatment
    1