BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTICAL FIBER 200 MICRON STANDARD SINGLE USE

    MDR report key: 14118113 · Received April 15, 2022

    Report

    Report Number
    3005580113-2022-00046
    Event Type
    Injury
    Date Received
    April 15, 2022
    Date of Event
    March 18, 2022
    Report Date
    April 15, 2022
    Manufacturer
    QUANTA SYSTEM S.P.A
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PROCODE: RHN.

    Additional Manufacturer Narrative · 0

    CORRECTION: D2: COMMON NAME: STERILE SURGICAL LASER FIBERS; PRODUCT CODE: GEX.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORTER, THEY WERE ALMOST DONE WITH THE PROCEDURE WHEN THEY LOST THE AIMING BEAM. THE FIBER HAD BROKE AT THE POINT OF DEFLECTION IN THE SCOPE. THEY WERE ABLE TO RECOVER THE FIBER. NO FIBER WAS INSIDE THE BODY AND THEY WERE DONE WITH THE CASE BY THIS TIME. IT WAS FURTHER REPORTED THAT THE PATIENT WOULD UNDERGO AN ADDITIONAL PROCEDURE UNDER ANESTHESIA AT ANOTHER DATE.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173635 OPTICAL FIBER 200 MICRON STANDARD SINGLE USE GEX QUANTA SYSTEM S.P.A A210613

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other