BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMENIS PULSE 50H

    MDR report key: 13797934 · Received March 17, 2022

    Report

    Report Number
    3004135191-2022-00008
    Event Type
    Malfunction
    Date Received
    March 17, 2022
    Date of Event
    March 7, 2022
    Report Date
    March 17, 2022
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEX
    UDI-DI
    07290109140537
    PMA / PMN Number
    K170121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING THE REPORTER TO REQUEST ADDITIONAL INFORMATION WHICH HAD BEEN PROVIDED. ACCORDING TO THE REPORTER, HE CHECKED THE SYSTEM THE NEXT DAY AND THE AIMING BEAM LIGHT CAME ON AND STAYED ON - HE COULD NOT REPRODUCE THE COMPLAINT. A REVIEW OF THE SUBJECT DEVICE DHR CONFIRMED THAT THE SUBJECT DEVICE WAS MANUFACTURED AND TESTED ACCORDING TO RELEVANT PROCEDURES, TESTED BEFORE RELEASE, AND SHIPPED ACCORDING TO MANUFACTURER'S SPECIFICATIONS. THE SYSTEM WAS MANUFACTURED ON 21-FEB-2019 AND INSTALLED AT THE CUSTOMER'S SITE ON 7-OCT-2019. A TWO YEAR HISTORICAL REVIEW OF SIMILAR COMPLAINTS REVEALED THAT THE SAME ISSUE OF AIMING BEAM FAILURE HAS NOT LED TO SERIOUS INJURY IN THE PAST. A LUMENIS SERVICE ENGINEER VISITED THE SITE SEVEN (7) DAYS AFTER THE REPORTED EVENT AND EXAMINED THE LASER SYSTEM. THE ENGINEER WAS UNABLE TO DUPLICATE THE PROBLEM AND FOUND NO ISSUES WITH AIMING BEAM. TECH STATED: "SOUNDS LIKE POSSIBLY TOO MUCH POWER WAS SENT TO FIBER AT TIME OF REPORTED ISSUE, 200 MICRON FIBERS HAVE A LIMIT OF 40W, HEAT WILL KILL THE 200 MICRON FIBERS PRETTY QUICK, TAKING A PAUSE DURING FIRING CAN HELP EXTEND THE LIFE OF THE FIBER". THE ENGINEER VERIFIED ALIGNMENT AND PERFORMED POWER CHECK. ALL POWER WITHIN SPECIFICATIONS. THE DEVICE WAS FOUND TO HAVE MET LUMENIS SPECIFICATIONS AND READY FOR USE. A REVIEW OF SYSTEM RISK FILES ((B)(4)) REVEALED RISK #2.3.2; HW FAILURE" WHICH HAVE THE POTENTIAL TO LEAD TO PROLONGED PROCEDURE. THE RISK HAS BEEN QUANTIFIED AND FOUND TO BE REMOTE, AND THE RISK LIKELIHOOD HAS BEEN CHARACTERIZED AND DOCUMENTED AS ACCEPTABLE WITHIN FULL RISK ASSESSMENT. ALTHOUGH THE ENGINEER WAS UNABLE TO DUPLICATE THE MALFUNCTIONED, IN THIS CASE, THE PATIENT WAS AWAKENED FROM ANESTHESIA & THE PROCEDURE WAS SUBSEQUENTLY CANCELLED. ALTHOUGH THERE WAS NO REPORT OF INJURY ASSOCIATED WITH THIS EVENT, LUMENIS BELIEVES THAT SUBJECTING A PATIENT TO ANOTHER ROUND OF ANESTHESIA CARRIES INHERENT RISKS, AND IN AN ABUNDANCE OF CAUTION, LUMENIS IS REPORTING THIS EVENT. LUMENIS IS CLOSING THIS COMPLAINT, BUT WILL CONTINUE TO MONITOR THE ISSUE; COMPLAINT TRENDING WILL CONTINUE TO MONITOR PER GLOBAL COMPLAINT HANDLING SOP ((B)(4)) AND PER POST MARKETING SURVEILLANCE PROCEDURE ((B)(4)).

    Description of Event or Problem · 0

    A USER FACILITY REPORTED THAT DURING A LITHOTRIPSY PROCEDURE IN WHICH A LUMENIS PULSE 50 WAS BEING UTILIZED, THE AIMING BEAM DISAPPEARED. THE USER FACILITY TRIED TO TROUBLESHOOT FOR FIFTEEN (15) MINUTES, BUT THE LASER COULD NO LONGER BE USED. UNABLE TO COMPLETE THE PROCEDURE, THE PATIENT WAS AWAKENED FROM GENERAL ANESTHESIA AND THE CASE NEEDED TO BE RESCHEDULED. 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
    615823 LUMENIS PULSE 50H HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) GEX LUMENIS LTD. LUMENIS PULSE 50H 07290109140537

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown