BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIGUIDE® DCYL CYLINDRICAL DIFFUSER

    MDR report key: 21839206 · Received April 15, 2025

    Report

    Report Number
    21839206
    Event Type
    Malfunction
    Date Received
    April 15, 2025
    Date of Event
    April 4, 2025
    Report Date
    April 9, 2025
    Manufacturer
    PINNACLE BIOLOGICS, INC.
    Product Code
    MVG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD THE PROCEDURE 'ROBOTIC NAVIGATIONAL BRONCHOSCOPY WITH RETREAT PHOTODYNAMIC THERAPY'. DURING THE LASER PORTION OF THE PHOTODYNAMIC THERAPY A PIECE OF THE PDT [PHOTODYNAMIC THERAPY] FIBER BROKE OFF IN THE PATIENT. MD WAS ABLE TO RETRIEVE THE BROKEN PIECE OF THE PDT FIBER AND REMOVE IT FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116335 OPTIGUIDE® DCYL CYLINDRICAL DIFFUSER SYSTEM, LASER, FIBER OPTIC, PHOTODYNAMIC THERAPY MVG PINNACLE BIOLOGICS, INC. 225 DI24045

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male