BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICOSURE

    MDR report key: 19243815 · Received May 3, 2024

    Report

    Report Number
    1222993-2024-00023
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Report Date
    May 3, 2024
    Manufacturer
    CYNOSURE LLC
    Product Code
    GEX
    PMA / PMN Number
    K210226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD CONFIRMS THAT THE PRODUCT PASSED AND MET ALL REQUIREMENTS BEFORE RELEASING. FIELD SITE ENGINEER ARRIVED ON SITE AND EVALUATED THE DEVICE. FSE CONFIRMED PDU PCB HEATER RELAY FAILED AND HAD STARTED A FIRE WITHIN THE LASER. TOP OF PDU PCB WAS BURNT AND SOOT WAS FOUND WITHIN THE DEVICE. LABELS INCLUDING PART NUMBER AND REVISION NUMBER ON THE PDU PCB LABELS WERE BURNED AND UNREADABLE. CABLES AT TOP OF PDU TO CPU WERE ALSO BURNT AND DAMAGED. ACCORDING TO FSE, "BASED ON THE HEATER RELAY STYLE, THE PDU WAS LIKELY AN OLDER MODEL (710-0173-300)." TO RESOLVE THE ISSUE, THE LATEST REVISION OF THE PDU PCB (710-0173-410) AND CABLES WERE ORDERED TO REPLACE DAMAGED PARTS. FSE PERFORMED A COMPLETE REASSIGNMENT OF DECK AND REPLACED PARTS AS NEEDED. THIS IS CONSIDERED REPORTABLE SINCE THE DEVICE MALFUNCTIONED AND IF THE MALFUNCTION WERE TO REOCCUR IT COULD POTENTIALLY BE A SERIOUS INJURY EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SMOKE CAME OUT FROM THE PICOSURE CAUSING THE FIRE ALARM TO GO OFF. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146054 PICOSURE PICOSURE GEX CYNOSURE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown