BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMENIS PULSE 30H

    MDR report key: 10916201 · Received November 29, 2020

    Report

    Report Number
    3004135191-2020-00090
    Event Type
    Malfunction
    Date Received
    November 29, 2020
    Date of Event
    November 25, 2020
    Report Date
    November 29, 2020
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEX
    UDI-DI
    07290109140698
    PMA / PMN Number
    K170121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE MEDWATCH REPORT, LUMENIS IS NOT THE MANUFACTURER OF THE FIBERS THAT WERE REPORTEDLY, "LASER FIBER ON THE OUTSIDE OF THE PATIENT IS LIGHTING UP." THE MANUFACTURER OF THE FIBER HAS BEEN MADE AWARE OF THE FIBER ISSUE. A LUMENIS SERVICE ENGINEER VISITED THE SITE THREE (3) DAYS AFTER THE REPORTED EVENT, AND WAS NOT ABLE TO DUPLICATE THE ALLEGED FAILURE. UPON INSPECTION AND FULL OPTIC EVALUATION, THE ENGINEER FOUND THAT THE SYSTEM MEETS LUMENIS SPECIFICATION, AND IS READY FOR USE. BASED ON THE INFORMATION ABOVE THERE IS NO EVIDENCE THAT A LUMENIS PRODUCT HAD MALFUNCTIONED IN THIS EVENT. IN AN ABUNDANCE OF CAUTION, LUMENIS IS REPORTING THIS MALFUNCTION IN RESPONSE TO THE USER FACILITY'S MEDWATCH REPORT 2300720000-2020-8010. LUMENIS IS CLOSING THIS COMPLAINT, BUT WILL CONTINUE TO MONITOR THIS FAILURE MODE; COMPLAINT TRENDING WILL CONTINUE TO MONITOR PER GLOBAL COMPLAINT HANDLING SOP (DOC NO. (B)(4)), AND PER POST MARKETING SURVEILLANCE PROCEDURE (DOC NO.: (B)(4)).

    Description of Event or Problem · 1

    ON 25-NOV-2020, A LUMENIS RECEIVED A USER SUBMITTED MEDWATCH REPORT 2300720000-2020-8010 IN WHICH THE DESCRIPTION OF THE EVENT READS, "WHEN THEY ARE USING IT (LUMENIS PULSE 30H) THE (NON-LUMENIS) LASER FIBER ON THE OUTSIDE OF THE PATIENT IS LIGHTING UP, TRIED 3 DIFFERENT LASER FIBERS AND THE ALL DID THAT." "THE VENDOR (LUMENIS) CAME OUT AND VERIFIED MACHINE OPERATION AND BELIEVES THE PROBLEM IS THE (NON-LUMENIS) FIBER THAT WAS USED." NO REPORT OF PATIENT COMPLICATIONS WAS RECEIVED, AND NO REPORT WAS RECEIVED ALLEGING THE DEVICE MALFUNCTION CAUSED, OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381367 LUMENIS PULSE 30H HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) GEX LUMENIS LTD. LUMENIS PULSE 30H 07290109140698

    Patients

    Seq Age Sex Outcome Treatment
    1