BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER HOLMIUM LASER FIBER

    MDR report key: 9274068 · Received November 4, 2019

    Report

    Report Number
    1037955-2019-00050
    Event Type
    Malfunction
    Date Received
    November 4, 2019
    Date of Event
    September 5, 2019
    Report Date
    September 9, 2019
    Manufacturer
    DORNIER MEDTECH AMERICA, INC.
    Product Code
    GEX
    UDI-DI
    00810116020348
    PMA / PMN Number
    K152591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE IDENTIFIED FIBER WAS NOT AVAILABLE FOR EVALUATION FROM THE COMPLAINT FACILITY. NO INDICATIONS WERE REVEALED IN THIS INVESTIGATION THAT THE IDENTIFIED PRODUCTION LOT WAS NOT MANUFACTURED IN ACCORDANCE TO APPLICABLE DORNIER SPECIFICATIONS AND OPERATED AS INTENDED PRIOR TO RELEASE BY PRODUCTION PERSONNEL. IT CAN BE CONFIRMED EACH HOLMIUM FIBER IS SUBJECT TO VISUAL DEFECT AND PERFORMANCE (POWER TESTING) EVALUATION PRIOR TO RELEASE FOR DISTRIBUTION. THE DISTAL TIP OF EACH HOLMIUM FIBER UNIT IS MAGNIFIED AND VERIFIED FOR ACCEPTABLE STANDARD AND EACH UNIT IS AFFIXED AROUND THE APPLICABLE BEND TEST FIXTURE TO ENSURE FLEXIBILITY IS WITHIN SPECIFICATION. THIS COMPLAINT IS UNABLE TO BE CONFIRMED AS NO UNIT WAS OBTAINABLE FOR EVALUATION AND THIS INVESTIGATION DID NOT REVEAL DEVIATIONS ASSOCIATED WITH THE IDENTIFIED PRODUCTION LOT, HOL200S LOT F2619S. IT IS ACKNOWLEDGED HOLMIUM FIBERS ARE FRAGILE AND MUST BE HANDLED WITH UTMOST CARE AS INDICATED IN THE APPLICABLE HOLMIUM FIBER INSTRUCTION FOR USE, QSF-670. THE COMPLAINT WAS REPORTED TO DMTA QUALITY FIRST VIA MEDWATCH REPORT MW5089801 ON 8 OCTOBER 2019. THE TERRITORY ASSIGNED SALES REPRESENTATIVE WAS CONTACTED REGARDING THE EVENT WHICH OCCURRED (B)(6) 2019. IT WAS IDENTIFIED THE RESPONSIBLE REPRESENTATIVE DID NOT FORWARD COMPLAINT DETAILS TO QUALITY UPON HER RECEIPT OF THE COMPLAINT 9 SEPTEMBER 2019. A CAPA WAS INITIATED IN RESPONSE TO THIS IDENTIFICATION.

    Description of Event or Problem · 1

    COMPLAINANT REPORTED A LASER FIBER BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068997 DORNIER HOLMIUM LASER FIBER HOLMIUM LASER FIBER GEX DORNIER MEDTECH AMERICA, INC. HOL200S F2619S 00810116020348

    Patients

    Seq Age Sex Outcome Treatment
    1