BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OAF FIBER

    MDR report key: 11805686 · Received May 11, 2021

    Report

    Report Number
    3004378299-2021-00073
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    March 29, 2021
    Report Date
    November 12, 2021
    Manufacturer
    QUANTA SYSTEM S.P.A.
    Product Code
    GEX
    UDI-DI
    08033945936723
    PMA / PMN Number
    K131473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OPTICAL FIBER TIP BROKEN: IMPOSSIBLE TO DETERMINE THE ROOT CAUSE AS RETURNED NOT STERILE. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

    Description of Event or Problem · 0

    FIBER TIP BROKE INSIDE THE PATIENT. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

    Additional Manufacturer Narrative · 1

    OPTICAL FIBER TIP BROKEN. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED. WE ARE WAITING FOR ADDITIONAL INFORMATION FROM THE DISTRIBUTOR.

    Description of Event or Problem · 1

    FIBER TIP BROKE INSIDE THE PATIENT. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706684 OAF FIBER SURGICAL LASER FIBER GEX QUANTA SYSTEM S.P.A. OAF702711 A205120 08033945936723

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown