BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMENIS PULSE120H

    MDR report key: 9382923 · Received November 27, 2019

    Report

    Report Number
    3004135191-2019-00135
    Event Type
    Malfunction
    Date Received
    November 27, 2019
    Date of Event
    November 1, 2019
    Report Date
    November 27, 2019
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEX
    UDI-DI
    07290109140513
    PMA / PMN Number
    K170121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A LUMENIS SERVICE ENGINEER VISITED THE SITE SIX (6) DAYS AFTER THE REPORTED EVENT AND EXAMINED THE LASER SYSTEM. THE ENGINEER FOUND POWER CORD HAD EXPOSED WIRES AT STRAIN RELIEF, AND UPON OPENING POWER PLUG, FOUND WHITE WIRE WAS DISCONNECTED. ON INITIAL TURN ON, SYSTEM DISPLAYING F203, 208. HEAVY DUST WAS CLEANED FROM INSIDE OF SYSTEM. COOLANT FILTERS WAS REPLACED AND CYCLED NEW COOLANT THROUGH SYSTEM. UPGRADED SYSTEM SOFTWARE FROM (B)(4) TO (B)(4), BUT ERRORS PERSIST. ORDERED PARTS: HV PMCU, MMCU, AND CHARGER. THE ENGINEER WILL RETURNED AND REPLACED THE MOTHERBOARD PCB ASSEMBLY. 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 SUBJECT SYSTEM WAS MANUFACTURED ON 08-OCT-2015 AND INSTALLED AT THE CUSTOMERS SITE ON 08-JAN-2016. A REVIEW OF SUBJECT DEVICE PRODUCT RISK FILE (RD-1124690_AD) REVEALED RISK # 2.4.2; "SYSTEM FAILURE" WHICH HAS THE POTENTIAL TO LEAD TO PROLONGED PROCEDURE -OR- INEFFECTIVE TREATMENT, WHICH MAY REQUIRE RE-OPERATION. THE RISK HAS BEEN QUANTIFIED AND FOUND TO BE REMOTE, AND THE RISK HAS BEEN CHARACTERIZED AND DOCUMENTED AS ACCEPTABLE WITHIN A FULL RISK ASSESSMENT. ALTHOUGH THE DEVICE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO ANY CHANGE IN THE PATIENT'S CONDITION, IT IS UNCERTAIN IF THE USER FACILITY HAD TO USE THE ALTERNATE DEVICE AS INTERVENTION TO PREVENT PERMANENT DAMAGE. IN AN ABUNDANCE OF CAUTION, LUMENIS IS REPORTING THIS MALFUNCTION. THE MOTHERBOARD PCB ASSEMBLY IS EXPECTED TO BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. ONCE A CAUSE FOR THE REPORTED EVENT HAS BEEN DETERMINED AND IF THERE WILL BE A SIGNIFICANT CHANGE, THEN LUMENIS WILL FILE A FOLLOW-UP MDR. LUMENIS 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

    A USER FACILITY REPORTED THAT DURING A PROCEDURE IN WHICH A LUMENIS PULSE 120 LASER WAS BEING UTILIZED, SPARKS WERE SEEN COMING FROM THE BACK OF LASER AND THE UNIT STOPPED WORKING. A BACKUP LASER SYSTEM WAS BROUGHT IN TO COMPLETE THE PROCEDURE; NO REPORT OF PATIENT INJURY WAS RECEIVED, NOR ANY REPORT THAT THE MALFUNCTION CAUSED OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180233 LUMENIS PULSE120H HOLMIUM (HO:YAG) SURGICAL LASERS AND DELIVERY DEVICE GEX LUMENIS LTD. LUMENIS PULSE 120H 07290109140513

    Patients

    Seq Age Sex Outcome Treatment
    1